HenriLD/FDA_Docs · Datasets at Hugging Face

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11,187	TENORMIN® (atenolol) TABLETS DESCRIPTION TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy 3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formu...	custom-source	2025-02-12T13:44:39.958713	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf', 'application_number': 18240, 'submission_type': 'SUPPL ', 'submission_number': 31}
11,189	XANAX® alprazolam tablets, USP CIV DESCRIPTION XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzod...	custom-source	2025-02-12T13:44:39.960219	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s045lbl.pdf', 'application_number': 18276, 'submission_type': 'SUPPL ', 'submission_number': 45}
11,188	NDA 18-264/S-025 Page 3 Dantrium® Intravenous (dantrolene sodium for injection) DESCRIPTION: Dantrium Intravenous is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium Intravenous is supplied in 70 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, a...	custom-source	2025-02-12T13:44:39.997275	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf', 'application_number': 18264, 'submission_type': 'SUPPL ', 'submission_number': 25}
11,191	K-TAB® (potassium chloride extended-release tablets, USP) DESCRIPTION K-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, U...	custom-source	2025-02-12T13:44:40.354790	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf', 'application_number': 18279, 'submission_type': 'SUPPL ', 'submission_number': 34}
11,190	K-TAB® (potassium chloride extended-release tablets, USP) DESCRIPTION K-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 750 m...	custom-source	2025-02-12T13:44:40.469034	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf', 'application_number': 18279, 'submission_type': 'SUPPL ', 'submission_number': 33}
11,192	Page 3 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNING APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN...	custom-source	2025-02-12T13:44:40.549538	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 44}
11,193	Page 3 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNING SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 A...	custom-source	2025-02-12T13:44:40.555643	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 46}
11,195	company logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND...	custom-source	2025-02-12T13:44:40.753305	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 50}
11,196	N 016608/S-103 N 018281/S-051 N 020234/S-035 N 018927/S-044 FDA Approved labeling dated 01/16/2014 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) ...	custom-source	2025-02-12T13:44:40.928366	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 51}
11,197	company logo NDA 016608/S‐105 NDA 018281/S‐053 NDA 018927/S‐046 NDA 020234/S‐038 FDA Approved labeling dated 02/15/2013 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamaz...	custom-source	2025-02-12T13:44:41.010911	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 53}
11,194	Novartis Logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-...	custom-source	2025-02-12T13:44:41.041974	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 48}
11,198	NDA 016608/S-107 NDA 018281/S-055 NDA 018927/S-048 NDA 020234/S-040 FDA Approved Labeling Text dated 12/11/2012 Page 1 company logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended...	custom-source	2025-02-12T13:44:41.202453	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 55}
11,199	1 Visken® T2007-60 Visken® (pindolol) tablets, USP Rx only DESCRIPTION Visken ® (pindolol), a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol. Its structural formula is: Pindolol is a white to off-white odor...	custom-source	2025-02-12T13:44:41.250252	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf', 'application_number': 18285, 'submission_type': 'SUPPL ', 'submission_number': 34}
11,201	structural formula Lopressor HCT® metoprolol tartrate USP and hydrochlorothiazide USP 50/25 Tablets 100/25 Tablets 100/50 Tablets Beta Blocker/Diuretic Antihypertensive Rx only Prescribing Information DESCRIPTION Lopressor HCT has the antihypertensive effect of Lopressor®, metoprolol ...	custom-source	2025-02-12T13:44:41.413233	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf', 'application_number': 18303, 'submission_type': 'SUPPL ', 'submission_number': 35}
11,203	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYMPHAZURIN™1% safely and effectively. See full prescribing information for LYPHAZURIN™ 1%. LYMPHAZURIN™ 1% (Isosulfan Blue) AQUEOUS SOULTION Initial U.S. Approval: 1981 ----------------------------RECEN...	custom-source	2025-02-12T13:44:41.529174	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018310s011lbl.pdf', 'application_number': 18310, 'submission_type': 'SUPPL ', 'submission_number': 11}
11,202	company logo 2 451106E/Revised: August 2013 3 4 Sensorcaine® (bupivacaine HCl Injection, USP) 5 Sensorcaine®-MPF (bupivacaine HCl Injection, USP) 6 Sensorcaine® with Epinephrine (b...	custom-source	2025-02-12T13:44:41.637647	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf', 'application_number': 18304, 'submission_type': 'SUPPL ', 'submission_number': 45}
11,204	NDA 018327/S-005 Page 5 Xenon Xe 133 Gas Rx only Diagnostic DESCRIPTION Xe...	custom-source	2025-02-12T13:44:41.670803	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018327s005lbl.pdf', 'application_number': 18327, 'submission_type': 'SUPPL ', 'submission_number': 5}
11,200	Lopressor HCT ® Lopressor HCT® T2007-77 metoprolol tartrate USP and hydrochlorothiazide USP 50/25 Tablets 100/25 Tablets 100/50 Tablets Beta Blocker/Diuretic Antihypertensive Rx only Prescribing Information DESCRIPTION Lopressor HCT has the antihypertensive effect of Lopressor ®, metoprolol tartrate, a selective bet...	custom-source	2025-02-12T13:44:41.714701	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf', 'application_number': 18303, 'submission_type': 'SUPPL ', 'submission_number': 32}
11,207	CARAFATE® (sucralfate) Suspension DESCRIPTION CARAFATE Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. st ruc tur al fo rm ula ...	custom-source	2025-02-12T13:44:41.919575	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf', 'application_number': 18333, 'submission_type': 'SUPPL ', 'submission_number': 34}
11,206	DESCRIPTION CARAFATE Tablets contain sucralfate and sucralfate is an a-D-glucopyranoside, ß-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate. Also contain: D & C Red #30 Lake, FD&C Blue #1 Lake, magnesium stearate, microcrystalline cell...	custom-source	2025-02-12T13:44:42.005280	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf', 'application_number': 18333, 'submission_type': 'SUPPL ', 'submission_number': 32}
11,205	9676002 CAPSULES, ORAL SUSPENSION and SUPPOSITORIES INDOCIN® (INDOMETHACIN) Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardi...	custom-source	2025-02-12T13:44:42.193267	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf', 'application_number': 18332, 'submission_type': 'SUPPL ', 'submission_number': 30}
11,208	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:42.254698	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf', 'application_number': 18337, 'submission_type': 'SUPPL ', 'submission_number': 32}
11,210	CAPOTEN® (Captopril Tablets, USP) Rx Only WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue Capoten as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity DESC...	custom-source	2025-02-12T13:44:42.286344	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf', 'application_number': 18343, 'submission_type': 'SUPPL ', 'submission_number': 84}
11,209	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:42.391966	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf', 'application_number': 18337, 'submission_type': 'SUPPL ', 'submission_number': 34}
11,213	Roxane Laboratories, Inc. Columbus, Ohio 43216 LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USP Rx only WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for...	custom-source	2025-02-12T13:44:42.551314	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf', 'application_number': 18421, 'submission_type': 'SUPPL ', 'submission_number': 27}
11,212	AYGESTIN® (norethindrone acetate tablets, USP) Rx only DESCRIPTION AYGESTIN® (norethindrone acetate tablets, USP) - 5 mg oral tablets. AYGESTIN®, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, ...	custom-source	2025-02-12T13:44:42.569373	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf', 'application_number': 18405, 'submission_type': 'SUPPL ', 'submission_number': 23}
11,214	LOPID   (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; hydroxypropyl cell...	custom-source	2025-02-12T13:44:42.633844	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 41}
11,215	LOPID® (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; ...	custom-source	2025-02-12T13:44:42.791953	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 48}
11,216	LOPID® (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose,...	custom-source	2025-02-12T13:44:42.960026	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 50}
11,218	LOPID (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; hydroxy...	custom-source	2025-02-12T13:44:43.148431	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 54}
11,219	9676203 TABLETS DOLOBID® (DIFLUNISAL) Cardiovascular Risk • NSAIDS may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardi...	custom-source	2025-02-12T13:44:43.187758	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf', 'application_number': 18445, 'submission_type': 'SUPPL ', 'submission_number': 58}
11,217	LOPID (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil...	custom-source	2025-02-12T13:44:43.342655	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 53}
11,221	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:43.593425	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf', 'application_number': 18452, 'submission_type': 'SUPPL ', 'submission_number': 25}
11,220	NDA 18-449/S-039 NDA 17-643/S-072 Page 3 Intralipid® 20% A 20% I.V. Fat Emulsion In Excel® Container DESCRIPTION INTRALIPID® 20% (A 20% INTRAVENOUS FAT EMULSION) IS A STERILE, NON-PYROGENIC FAT EMULSION PREPARED FOR INTRAVENOUS ADMINISTRATION AS A SOURCE OF CALORIES AND ESSENTIAL FATTY ACIDS. I...	custom-source	2025-02-12T13:44:43.620389	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf', 'application_number': 18449, 'submission_type': 'SUPPL ', 'submission_number': 39}
11,223		custom-source	2025-02-12T13:44:43.623965	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf', 'application_number': 18461, 'submission_type': 'SUPPL ', 'submission_number': 50}
11,222	s t ructural form u l a s t r u ctural f o r m u l a CIV TALACEN® Pentazocine hydrochloride, USP, and acetaminophen, USP Hepatotoxicity TALACEN contains pentazocine hydrochloride and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in li...	custom-source	2025-02-12T13:44:43.664681	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf', 'application_number': 18458, 'submission_type': 'SUPPL ', 'submission_number': 16}
11,225	NDA 18-469/S-052 Page 3 BSS PLUS® STERILE IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a ...	custom-source	2025-02-12T13:44:43.820792	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 52}
11,227	NDA 018469/S-056 Page 4 Labeling for BSS PLUS 250 mL (Part I) and 10 mL (Part II) Bottle kit BSS PLUS 250 mL (Part 1) container label 250mL Single Patient Use NDC 0065-0800-25 BSS PLUS* STERILE INTRAOCULAR IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose and glutathione) After addition o...	custom-source	2025-02-12T13:44:43.974332	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 56}
11,224	NDA 18-469/S-040 & S-041 Page 3 Package Insert (for combined 250mL and 500 mL sizes) BSS PLUS® STERILE INTRAOCULAR IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) DESCRIPTION: BSS PLUS ® is a sterile intraocular irrigating solution for use during all intraocu...	custom-source	2025-02-12T13:44:44.040748	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 41}
11,226	...	custom-source	2025-02-12T13:44:44.174394	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 55}
11,228	s tr uct u ral formu la PROCARDIA® (nifedipine) CAPSULES For Oral Use DESCRIPTION PROCARDIA® (nifedipine) is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5-pyridinedicarbox...	custom-source	2025-02-12T13:44:44.254096	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf', 'application_number': 18482, 'submission_type': 'SUPPL ', 'submission_number': 51}
11,230	NDA 18-469/S-052 Page 3 BSS PLUS® STERILE IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a ...	custom-source	2025-02-12T13:44:44.267397	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf', 'application_number': 18489, 'submission_type': 'SUPPL ', 'submission_number': 52}
11,229	FUR:R27 FUROSEMIDE TABLETS, USP 20 mg, 40 mg and 80 mg Rx only WARNING: Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is r...	custom-source	2025-02-12T13:44:44.495263	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf', 'application_number': 18487, 'submission_type': 'SUPPL ', 'submission_number': 43}
11,233	s tructural formula Propranolol hydrochloride extended-release capsules Rx only DESCRIPTION Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural...	custom-source	2025-02-12T13:44:44.688134	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf', 'application_number': 18553, 'submission_type': 'SUPPL ', 'submission_number': 37}
11,232	Rev. July 2005 Lozol® (indapamide) 1.25 mg tablets Rx only DESCRIPTION Lozol® (indapamide) is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It ...	custom-source	2025-02-12T13:44:44.721296	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf', 'application_number': 18538, 'submission_type': 'SUPPL ', 'submission_number': 28}
11,231	JANSSEN PHARMACEUTICALS NIZORAL (KETOCONAZOLE) TABLETS WARNING: NIZORAL® Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a f...	custom-source	2025-02-12T13:44:44.767570	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf', 'application_number': 18533, 'submission_type': 'SUPPL ', 'submission_number': 41}
11,234	HLR 052803 FANSIDAR brand of sulfadoxine and pyrimethamine TABLETS Rx only WARNING: FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF FANSIDAR HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS. FANSIDAR PROPHYLAXIS MUST BE DISCONTINUED AT THE FIRST APPE...	custom-source	2025-02-12T13:44:44.908841	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf', 'application_number': 18557, 'submission_type': 'SUPPL ', 'submission_number': 15}
11,236	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U....	custom-source	2025-02-12T13:44:45.174083	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf', 'application_number': 18563, 'submission_type': 'SUPPL ', 'submission_number': 57}
11,237	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U....	custom-source	2025-02-12T13:44:45.208190	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf', 'application_number': 18564, 'submission_type': 'SUPPL ', 'submission_number': 59}
11,235	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U....	custom-source	2025-02-12T13:44:45.223246	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf', 'application_number': 18562, 'submission_type': 'SUPPL ', 'submission_number': 56}
11,241	Topicort® (Desoximetasone) Ointment USP 0.05% For topical use only. Not for oral, ophthalmic, or intravaginal use. Rx only DESCRIPTION Topicort® (desoximetasone) Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical co...	custom-source	2025-02-12T13:44:45.617773	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf', 'application_number': 18594, 'submission_type': 'SUPPL ', 'submission_number': 7}
11,240	FUROSEMIDE FUROSEMIDE INJECTION, USP INJECTION, USP 10 mg/mL 10 mg/mL Rx Only Rx Only bar code WARNING Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose sch...	custom-source	2025-02-12T13:44:45.619530	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf', 'application_number': 18579, 'submission_type': 'SUPPL ', 'submission_number': 29}
11,239	CII NDA 018565/S-020 Page 4 PRESERVATIVE-FREE DURAMORPH (morphine sulfate injection, USP) Rx only Not For Use in Continuous Microinfusion Devices DESCRIPTION Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the...	custom-source	2025-02-12T13:44:45.641458	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf', 'application_number': 18565, 'submission_type': 'SUPPL ', 'submission_number': 20}
11,238	1 PRESERVATIVE-FREE DURAMORPH (morphine sulfate injection, USP) CII Rx only DESCRIPTION Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the sulfate salt, having the following structural formula: 7,8-Didehydro-4,5-epoxy-17-methyl-(5Į,6Į)-morphinan-3,6-diol su...	custom-source	2025-02-12T13:44:45.658525	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf', 'application_number': 18565, 'submission_type': 'SUPPL ', 'submission_number': 14}
11,243	N18602/S-063 Page 2 CARDIZEM® (diltiazem hydrochloride) Direct Compression Tablets Rx only DESCRIPTION Cardizem® (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, dilt...	custom-source	2025-02-12T13:44:45.882164	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf', 'application_number': 18602, 'submission_type': 'SUPPL ', 'submission_number': 63}
11,244	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda	custom-source	2025-02-12T13:44:45.986443	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf', 'application_number': 18609, 'submission_type': 'SUPPL ', 'submission_number': 33}
11,242	Reference ID: 3186262 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3186262 This label may...	custom-source	2025-02-12T13:44:46.019245	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf', 'application_number': 18594, 'submission_type': 'SUPPL ', 'submission_number': 8}
11,245	Heparin Sodium and 0.9% Sodium Chloride Injection in Plastic Container VIAFLEX Plus Container DESCRIPTION Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in hepar...	custom-source	2025-02-12T13:44:46.048635	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf', 'application_number': 18609, 'submission_type': 'SUPPL ', 'submission_number': 44}
11,246	nicotine polacrilex gum, 2mg STOP SMOKING AID ® FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY If you smoke 25 or more cigarettes a day: use Nicorette 4mg 40 PIECES, 2mg EACH GUM GUM 2mg 2mg COATED COATED Drug Facts Active ingredient Purpose (in each chewing piece) Nicotine polacrilex (equal to 2mg...	custom-source	2025-02-12T13:44:46.453334	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf', 'application_number': 18612, 'submission_type': 'SUPPL ', 'submission_number': 42}
11,249	NDA 18-613/S-011 Page 3 3 OVIDE® (malathion) Lotion, 0.5% NDC 99207-650-02 Ovide® (malathion) Lotion, 0.5% Rx Only For topical use only. Not for oral or ophthalmic use. DESCRIPTION OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, d...	custom-source	2025-02-12T13:44:46.535657	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf', 'application_number': 18613, 'submission_type': 'SUPPL ', 'submission_number': 11}
11,250	company logo NDC 51672-5276-4 Ovide® (malathion) Lotion, 0.5% Rx Only For topical use only. Not for oral or ophthalmic use. DESCRIPTION OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isop...	custom-source	2025-02-12T13:44:46.780327	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf', 'application_number': 18613, 'submission_type': 'SUPPL ', 'submission_number': 17}
11,251	TRENTAL® (pentoxifylline) Extended-Release Tablets, 400 mg DESCRIPTION TRENTAL® (pentoxifylline) extended-release tablets for oral administration contain 400 mg of the active drug and the follo...	custom-source	2025-02-12T13:44:46.906064	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf', 'application_number': 18631, 'submission_type': 'SUPPL ', 'submission_number': 41}
11,248	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:47.179612	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf', 'application_number': 18612, 'submission_type': 'SUPPL ', 'submission_number': 74}
11,252	Attachment 1 Page 1 Class Suicidality Labeling Language for Antidepressants [This section should be located at the beginning of the package insert with bolded font and enclosed in a black box] [Insert established name] Suicidality in Children and Adolescents Antidepressants increased the risk o...	custom-source	2025-02-12T13:44:47.323975	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 30}
11,247	0 0 0000-0000-00 Reference ID: 3522999 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3522999 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsat...	custom-source	2025-02-12T13:44:47.968196	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf', 'application_number': 18612, 'submission_type': 'SUPPL ', 'submission_number': 72}
11,253	1 PRESCRIBING INFORMATION 1 WELLBUTRIN® 2 (bupropion hydrochloride) 3 Tablets 4 5 Suicidality in Children and Adolescents 6 Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in 7 short-term studies in children and adolescents with Major Depressive Disorder (MDD) and ...	custom-source	2025-02-12T13:44:48.332920	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 33}
11,255	NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 4 PRESCRIBING INFORMATION WELLBUTRIN® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders: Antidepressants increa...	custom-source	2025-02-12T13:44:48.334464	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 39}
11,254	1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 PRESCRIBING INFORMATION WELLBUTRIN® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Di...	custom-source	2025-02-12T13:44:48.498204	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 38}
11,256	PRESCRIBING INFORMATION WELLBUTRIN® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young ad...	custom-source	2025-02-12T13:44:48.759435	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 43}
11,258	NDA 18-651/S-018 Page 3 500012 3E Rev 10/2002 MARINOL® (Dronabinol) Capsules DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl- 6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas: ...	custom-source	2025-02-12T13:44:48.820156	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf', 'application_number': 18651, 'submission_type': 'SUPPL ', 'submission_number': 18}
11,259	NDA 18-651/S-021 Page 3 500012 Rev Sep 2004 MARINOL® (Dronabinol) Capsules DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas: Dro...	custom-source	2025-02-12T13:44:48.872854	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf', 'application_number': 18651, 'submission_type': 'SUPPL ', 'submission_number': 21}
11,257	...	custom-source	2025-02-12T13:44:49.068559	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 46}
11,261	Locoid® (hydrocortisone butyrate) Ointment, 0.1% For topical use DESCRIPTION Locoid® (hydrocortisone butyrate) Ointment, 0.1% contains the topical corticosteroid, hydrocortisone bu...	custom-source	2025-02-12T13:44:49.116472	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf', 'application_number': 18652, 'submission_type': 'SUPPL ', 'submission_number': 10}
11,262	C:\Data\My Documents\Flagyl\Feb04proposed18657label.doc Last Saved On 03/04/04 6:37 PMBaxter Confidential Page 1 of 6 Metronidazole Injection, USP RTU® in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU and...	custom-source	2025-02-12T13:44:49.164398	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 27}
11,260	NDA 18-651/S-025 and S-026 Page 3 MARINOL® (dronabinol) Capsules DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas: Dronabinol, the activ...	custom-source	2025-02-12T13:44:49.201627	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf', 'application_number': 18651, 'submission_type': 'SUPPL ', 'submission_number': 26}
11,263	NDA 18-657/S-029 Page 5 *BAR CODE LOCATION ONLY 071959414 Baxter Metronidazole Injection, USP RTU® in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU® and...	custom-source	2025-02-12T13:44:49.461719	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 29}
11,265	Metronidazole Injection, USP in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP and other antibacterial drugs, Metronid...	custom-source	2025-02-12T13:44:49.591930	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 32}
11,264	NDA 018657/S-31 Page 3 Metronidazole Injection, USP RTU in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU and other antibacterial drugs, Metronidazole Injection, USP RTU shoul...	custom-source	2025-02-12T13:44:49.837945	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 31}
11,266	C I A 7 0 2 3 0 K Dextromethorphan Polistirex Extended-Release Suspension (Cough Suppressant) Contains No Fever Reducer or Pain Reliever 148 mL (5 fl oz) Alcohol-free Flavored Liquid Flavored Liquid FRONT LABEL 2 1/4" 2 7/8" 8137787 022014 NDC 63824-177-65 PT# C I A 60331 Reference ID: 3610277 (b) (4)...	custom-source	2025-02-12T13:44:50.006907	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf', 'application_number': 18658, 'submission_type': 'SUPPL ', 'submission_number': 30}
11,267	ACCUTANE® (isotretinoin) CAPSULES CAUSES BIRTH DEFECTS AVOID PREGNANCY CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result ...	custom-source	2025-02-12T13:44:50.150190	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 41}
11,268	ACCUTANE   (isotretinoin) CAPSULES CAUSES BIRTH DEFECTS DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can re...	custom-source	2025-02-12T13:44:50.256163	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 51}
11,269	3 NARRATION SCRIPT Revised 2/6/03 FLK100VID ACCUTANE PREGNANCY VIDEO Opening Segment “ACCUTANE® CANNOT BE TAKEN BY WOMEN WHO ARE PREGNANT, BECAUSE ACCUTANE CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. In this video we will see what can happen to an unborn baby if the baby’s mother takes Ac...	custom-source	2025-02-12T13:44:50.631979	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 52}
11,272	NDA 18-676/S-022 Page 5 Y36-002-487 PACKAGE INSERT HepatAmine® (8% Amino Acid Injection) Protect from light until use. DESCRIPTION Rx only HepatAmine (8% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 500 mL unit provides a total of 4...	custom-source	2025-02-12T13:44:50.777670	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf', 'application_number': 18676, 'submission_type': 'SUPPL ', 'submission_number': 22}
11,270	NDA 18-662/S054 Page 3 ACCUTANE (isotretinoin) CAPSULES Rx only CAUSES BIRTH DEFECTS DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extrem...	custom-source	2025-02-12T13:44:50.812734	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 54}
11,271	NDA 18-662/S-056 Page 11 ACCUTANE® (isotretinoin capsules) Rx only CAUSES BIRTH DEFECTS DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will r...	custom-source	2025-02-12T13:44:51.007416	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 56}
11,273	To reduce the development of drug- resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Trimethoprim i...	custom-source	2025-02-12T13:44:51.180242	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf', 'application_number': 18679, 'submission_type': 'SUPPL ', 'submission_number': 40}
11,275	NDA 18-680/S-060 Page 3 PROPOSED PRESCRIBING INFORMATION ParaGard® T 380A Intrauterine Copper Contraceptive Prescribing Information Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. ParaGard® T 380A Intrauterine Co...	custom-source	2025-02-12T13:44:51.280569	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf', 'application_number': 18680, 'submission_type': 'SUPPL ', 'submission_number': 60}
11,276	NDA 18681/S-027 Page 5 LD-442-1 Y36-002-845 Package Insert Lactated Ringer's Irrigation FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES Not For Injection By Usual Parenteral Routes Flexible Irrigation Container Rx only DESCRIPTION Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of ...	custom-source	2025-02-12T13:44:51.333293	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf', 'application_number': 18681, 'submission_type': 'SUPPL ', 'submission_number': 27}
11,274	TRIMETHOPRIM TABLETS, USP 2158 Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are...	custom-source	2025-02-12T13:44:51.334845	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf', 'application_number': 18679, 'submission_type': 'SUPPL ', 'submission_number': 44}
11,277	PMS Black Last Time Saved: 12/1/2009 8:56 AM Document Name: QEN-2313v3.qxp Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pres...	custom-source	2025-02-12T13:44:51.560339	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf', 'application_number': 18692, 'submission_type': 'SUPPL ', 'submission_number': 14}
11,278	MarcaineTM Bupivacaine Hydrochloride Injection, USP MarcaineTM With Epinephrine 1:200,000 (as bitartrate) Bupivacaine Hydrochloride and Epinephrine Injection, USP Rx only DESCRIPTION Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohyd...	custom-source	2025-02-12T13:44:51.704079	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf', 'application_number': 18692, 'submission_type': 'SUPPL ', 'submission_number': 15}
11,279	structural formula HALDOL® Decanoate 50 (haloperidol) HALDOL® Decanoate 100 (haloperidol) For IM Injection Only WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an incr...	custom-source	2025-02-12T13:44:51.880685	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf', 'application_number': 18701, 'submission_type': 'SUPPL ', 'submission_number': 54}
11,280	HALDOL® brand of haloperidol injection (For Immediate Release) WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen pla...	custom-source	2025-02-12T13:44:51.883257	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf', 'application_number': 18701, 'submission_type': 'SUPPL ', 'submission_number': 59}
11,281	HALDOL brand of haloperidol injection (For Immediate Release) WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with...	custom-source	2025-02-12T13:44:52.044694	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf', 'application_number': 18701, 'submission_type': 'SUPPL ', 'submission_number': 72}
11,282	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda	custom-source	2025-02-12T13:44:52.117561	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf', 'application_number': 18702, 'submission_type': 'SUPPL ', 'submission_number': 7}
11,283	ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% ACLOVATE® (alclometasone dipropionate ointment) Ointment, 0.05% Rx only For Dermatologic Use Only– Not for Ophthalmic Use. DESCRIPTION ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% and ACLOVATE® (alclometasone dipropionat...	custom-source	2025-02-12T13:44:52.223538	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf', 'application_number': 18702, 'submission_type': 'SUPPL ', 'submission_number': 11}
11,284	1 PRESCRIBING INFORMATION 1 ZANTAC® 150 2 (ranitidine hydrochloride) 3 Tablets, USP 4 5 ZANTAC® 300 6 (ranitidine hydrochloride) 7 Tablets, USP 8 9 ZANTAC® 25 10 (ranitidine hydrochloride effervescent) 11 EFFERdose® Tablets 12 13 ZANTAC® 150 14 (ranitidine hydrochloride effervescen...	custom-source	2025-02-12T13:44:52.319658	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf', 'application_number': 18703, 'submission_type': 'SUPPL ', 'submission_number': 65}
11,286	PRESCRIBING INFORMATION ZANTAC® 150 (ranitidine hydrochloride) Tablets, USP ZANTAC® 300 (ranitidine hydrochloride) Tablets, USP ZANTAC® 25 (ranitidine hydrochloride effervescent) EFFERdose® Tablets ZANTAC® (ranitidine hydrochloride) Syrup, USP DESCRIPTION...	custom-source	2025-02-12T13:44:52.384544	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf', 'application_number': 18703, 'submission_type': 'SUPPL ', 'submission_number': 68}
11,285	PRESCRIBING INFORMATION ZANTAC® 150 (ranitidine hydrochloride) Tablets, USP ZANTAC® 300 (ranitidine hydrochloride) Tablets, USP ZANTAC® 25 (ranitidine hydrochloride effervescent) EFFERdose® Tablets ZANTAC® (ranitidine hydrochloride) Syrup, USP DESCRIPTION...	custom-source	2025-02-12T13:44:52.418743	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf', 'application_number': 18703, 'submission_type': 'SUPPL ', 'submission_number': 67}
11,287	NDA 017963/S-063 NDA 018704/S-023 Page 4 Lopressor® metoprolol tartrate tablets, USP metoprolol tartrate injection, USP Rx only Prescribing Information DESCRIPTION Lopressor, metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, avail...	custom-source	2025-02-12T13:44:52.546346	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf', 'application_number': 18704, 'submission_type': 'SUPPL ', 'submission_number': 23}

11,187

TENORMIN® (atenolol) TABLETS DESCRIPTION TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy 3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formu...

custom-source

2025-02-12T13:44:39.958713

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf', 'application_number': 18240, 'submission_type': 'SUPPL ', 'submission_number': 31}

11,189

XANAX® alprazolam tablets, USP CIV DESCRIPTION XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzod...

custom-source

2025-02-12T13:44:39.960219

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s045lbl.pdf', 'application_number': 18276, 'submission_type': 'SUPPL ', 'submission_number': 45}

11,188

NDA 18-264/S-025 Page 3 Dantrium® Intravenous (dantrolene sodium for injection) DESCRIPTION: Dantrium Intravenous is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium Intravenous is supplied in 70 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, a...

custom-source

2025-02-12T13:44:39.997275

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf', 'application_number': 18264, 'submission_type': 'SUPPL ', 'submission_number': 25}

11,191

K-TAB® (potassium chloride extended-release tablets, USP) DESCRIPTION K-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, U...

custom-source

2025-02-12T13:44:40.354790

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf', 'application_number': 18279, 'submission_type': 'SUPPL ', 'submission_number': 34}

11,190

K-TAB® (potassium chloride extended-release tablets, USP) DESCRIPTION K-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 750 m...

custom-source

2025-02-12T13:44:40.469034

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf', 'application_number': 18279, 'submission_type': 'SUPPL ', 'submission_number': 33}

11,192

Page 3 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNING APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN...

custom-source

2025-02-12T13:44:40.549538

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 44}

11,193

Page 3 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNING SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 A...

custom-source

2025-02-12T13:44:40.555643

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 46}

11,195

company logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND...

custom-source

2025-02-12T13:44:40.753305

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 50}

11,196

N 016608/S-103 N 018281/S-051 N 020234/S-035 N 018927/S-044 FDA Approved labeling dated 01/16/2014 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) ...

custom-source

2025-02-12T13:44:40.928366

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 51}

11,197

company logo NDA 016608/S‐105 NDA 018281/S‐053 NDA 018927/S‐046 NDA 020234/S‐038 FDA Approved labeling dated 02/15/2013 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamaz...

custom-source

2025-02-12T13:44:41.010911

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 53}

11,194

Novartis Logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-...

custom-source

2025-02-12T13:44:41.041974

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 48}

11,198

NDA 016608/S-107 NDA 018281/S-055 NDA 018927/S-048 NDA 020234/S-040 FDA Approved Labeling Text dated 12/11/2012 Page 1 company logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended...

custom-source

2025-02-12T13:44:41.202453

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf', 'application_number': 18281, 'submission_type': 'SUPPL ', 'submission_number': 55}

11,199

1 Visken® T2007-60 Visken® (pindolol) tablets, USP Rx only DESCRIPTION Visken ® (pindolol), a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol. Its structural formula is: Pindolol is a white to off-white odor...

custom-source

2025-02-12T13:44:41.250252

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf', 'application_number': 18285, 'submission_type': 'SUPPL ', 'submission_number': 34}

11,201

structural formula Lopressor HCT® metoprolol tartrate USP and hydrochlorothiazide USP 50/25 Tablets 100/25 Tablets 100/50 Tablets Beta Blocker/Diuretic Antihypertensive Rx only Prescribing Information DESCRIPTION Lopressor HCT has the antihypertensive effect of Lopressor®, metoprolol ...

custom-source

2025-02-12T13:44:41.413233

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf', 'application_number': 18303, 'submission_type': 'SUPPL ', 'submission_number': 35}

11,203

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYMPHAZURIN™1% safely and effectively. See full prescribing information for LYPHAZURIN™ 1%. LYMPHAZURIN™ 1% (Isosulfan Blue) AQUEOUS SOULTION Initial U.S. Approval: 1981 ----------------------------RECEN...

custom-source

2025-02-12T13:44:41.529174

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018310s011lbl.pdf', 'application_number': 18310, 'submission_type': 'SUPPL ', 'submission_number': 11}

11,202

company logo 2 451106E/Revised: August 2013 3 4 Sensorcaine® (bupivacaine HCl Injection, USP) 5 Sensorcaine®-MPF (bupivacaine HCl Injection, USP) 6 Sensorcaine® with Epinephrine (b...

custom-source

2025-02-12T13:44:41.637647

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf', 'application_number': 18304, 'submission_type': 'SUPPL ', 'submission_number': 45}

11,204

NDA 018327/S-005 Page 5 Xenon Xe 133 Gas Rx only Diagnostic DESCRIPTION Xe...

custom-source

2025-02-12T13:44:41.670803

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018327s005lbl.pdf', 'application_number': 18327, 'submission_type': 'SUPPL ', 'submission_number': 5}

11,200

Lopressor HCT ® Lopressor HCT® T2007-77 metoprolol tartrate USP and hydrochlorothiazide USP 50/25 Tablets 100/25 Tablets 100/50 Tablets Beta Blocker/Diuretic Antihypertensive Rx only Prescribing Information DESCRIPTION Lopressor HCT has the antihypertensive effect of Lopressor ®, metoprolol tartrate, a selective bet...

custom-source

2025-02-12T13:44:41.714701

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf', 'application_number': 18303, 'submission_type': 'SUPPL ', 'submission_number': 32}

11,207

CARAFATE® (sucralfate) Suspension DESCRIPTION CARAFATE Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. st ruc tur al fo rm ula ...

custom-source

2025-02-12T13:44:41.919575

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf', 'application_number': 18333, 'submission_type': 'SUPPL ', 'submission_number': 34}

11,206

DESCRIPTION CARAFATE Tablets contain sucralfate and sucralfate is an a-D-glucopyranoside, ß-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate. Also contain: D & C Red #30 Lake, FD&C Blue #1 Lake, magnesium stearate, microcrystalline cell...

custom-source

2025-02-12T13:44:42.005280

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf', 'application_number': 18333, 'submission_type': 'SUPPL ', 'submission_number': 32}

11,205

9676002 CAPSULES, ORAL SUSPENSION and SUPPOSITORIES INDOCIN® (INDOMETHACIN) Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardi...

custom-source

2025-02-12T13:44:42.193267

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf', 'application_number': 18332, 'submission_type': 'SUPPL ', 'submission_number': 30}

11,208

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...

custom-source

2025-02-12T13:44:42.254698

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf', 'application_number': 18337, 'submission_type': 'SUPPL ', 'submission_number': 32}

11,210

CAPOTEN® (Captopril Tablets, USP) Rx Only WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue Capoten as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity DESC...

custom-source

2025-02-12T13:44:42.286344

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf', 'application_number': 18343, 'submission_type': 'SUPPL ', 'submission_number': 84}

11,209

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...

custom-source

2025-02-12T13:44:42.391966

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf', 'application_number': 18337, 'submission_type': 'SUPPL ', 'submission_number': 34}

11,213

Roxane Laboratories, Inc. Columbus, Ohio 43216 LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USP Rx only WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for...

custom-source

2025-02-12T13:44:42.551314

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf', 'application_number': 18421, 'submission_type': 'SUPPL ', 'submission_number': 27}

11,212

AYGESTIN® (norethindrone acetate tablets, USP) Rx only DESCRIPTION AYGESTIN® (norethindrone acetate tablets, USP) - 5 mg oral tablets. AYGESTIN®, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, ...

custom-source

2025-02-12T13:44:42.569373

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf', 'application_number': 18405, 'submission_type': 'SUPPL ', 'submission_number': 23}

11,214

LOPID   (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; hydroxypropyl cell...

custom-source

2025-02-12T13:44:42.633844

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 41}

11,215

LOPID® (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; ...

custom-source

2025-02-12T13:44:42.791953

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 48}

11,216

LOPID® (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose,...

custom-source

2025-02-12T13:44:42.960026

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 50}

11,218

LOPID (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; hydroxy...

custom-source

2025-02-12T13:44:43.148431

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 54}

11,219

9676203 TABLETS DOLOBID® (DIFLUNISAL) Cardiovascular Risk • NSAIDS may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardi...

custom-source

2025-02-12T13:44:43.187758

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018445s058lbl.pdf', 'application_number': 18445, 'submission_type': 'SUPPL ', 'submission_number': 58}

11,217

LOPID (Gemfibrozil Tablets, USP) DESCRIPTION LOPID® (gemfibrozil tablets, USP) is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil...

custom-source

2025-02-12T13:44:43.342655

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf', 'application_number': 18422, 'submission_type': 'SUPPL ', 'submission_number': 53}

11,221

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...

custom-source

2025-02-12T13:44:43.593425

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf', 'application_number': 18452, 'submission_type': 'SUPPL ', 'submission_number': 25}

11,220

NDA 18-449/S-039 NDA 17-643/S-072 Page 3 Intralipid® 20% A 20% I.V. Fat Emulsion In Excel® Container DESCRIPTION INTRALIPID® 20% (A 20% INTRAVENOUS FAT EMULSION) IS A STERILE, NON-PYROGENIC FAT EMULSION PREPARED FOR INTRAVENOUS ADMINISTRATION AS A SOURCE OF CALORIES AND ESSENTIAL FATTY ACIDS. I...

custom-source

2025-02-12T13:44:43.620389

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf', 'application_number': 18449, 'submission_type': 'SUPPL ', 'submission_number': 39}

11,223

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2025-02-12T13:44:43.623965

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf', 'application_number': 18461, 'submission_type': 'SUPPL ', 'submission_number': 50}

11,222

s t ructural form u l a s t r u ctural f o r m u l a CIV TALACEN® Pentazocine hydrochloride, USP, and acetaminophen, USP Hepatotoxicity TALACEN contains pentazocine hydrochloride and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in li...

custom-source

2025-02-12T13:44:43.664681

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf', 'application_number': 18458, 'submission_type': 'SUPPL ', 'submission_number': 16}

11,225

NDA 18-469/S-052 Page 3 BSS PLUS® STERILE IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a ...

custom-source

2025-02-12T13:44:43.820792

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 52}

11,227

NDA 018469/S-056 Page 4 Labeling for BSS PLUS 250 mL (Part I) and 10 mL (Part II) Bottle kit BSS PLUS 250 mL (Part 1) container label 250mL Single Patient Use NDC 0065-0800-25 BSS PLUS* STERILE INTRAOCULAR IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose and glutathione) After addition o...

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2025-02-12T13:44:43.974332

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 56}

11,224

NDA 18-469/S-040 & S-041 Page 3 Package Insert (for combined 250mL and 500 mL sizes) BSS PLUS® STERILE INTRAOCULAR IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) DESCRIPTION: BSS PLUS ® is a sterile intraocular irrigating solution for use during all intraocu...

custom-source

2025-02-12T13:44:44.040748

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 41}

11,226

...

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2025-02-12T13:44:44.174394

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf', 'application_number': 18469, 'submission_type': 'SUPPL ', 'submission_number': 55}

11,228

s tr uct u ral formu la PROCARDIA® (nifedipine) CAPSULES For Oral Use DESCRIPTION PROCARDIA® (nifedipine) is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5-pyridinedicarbox...

custom-source

2025-02-12T13:44:44.254096

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf', 'application_number': 18482, 'submission_type': 'SUPPL ', 'submission_number': 51}

11,230

NDA 18-469/S-052 Page 3 BSS PLUS® STERILE IRRIGATING SOLUTION (balanced salt solution enriched with bicarbonate, dextrose, and glutathione) DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a ...

custom-source

2025-02-12T13:44:44.267397

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf', 'application_number': 18489, 'submission_type': 'SUPPL ', 'submission_number': 52}

11,229

FUR:R27 FUROSEMIDE TABLETS, USP 20 mg, 40 mg and 80 mg Rx only WARNING: Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is r...

custom-source

2025-02-12T13:44:44.495263

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf', 'application_number': 18487, 'submission_type': 'SUPPL ', 'submission_number': 43}

11,233

s tructural formula Propranolol hydrochloride extended-release capsules Rx only DESCRIPTION Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural...

custom-source

2025-02-12T13:44:44.688134

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf', 'application_number': 18553, 'submission_type': 'SUPPL ', 'submission_number': 37}

11,232

Rev. July 2005 Lozol® (indapamide) 1.25 mg tablets Rx only DESCRIPTION Lozol® (indapamide) is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It ...

custom-source

2025-02-12T13:44:44.721296

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf', 'application_number': 18538, 'submission_type': 'SUPPL ', 'submission_number': 28}

11,231

JANSSEN PHARMACEUTICALS NIZORAL (KETOCONAZOLE) TABLETS WARNING: NIZORAL® Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a f...

custom-source

2025-02-12T13:44:44.767570

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf', 'application_number': 18533, 'submission_type': 'SUPPL ', 'submission_number': 41}

11,234

HLR 052803 FANSIDAR brand of sulfadoxine and pyrimethamine TABLETS Rx only WARNING: FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF FANSIDAR HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS. FANSIDAR PROPHYLAXIS MUST BE DISCONTINUED AT THE FIRST APPE...

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2025-02-12T13:44:44.908841

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf', 'application_number': 18557, 'submission_type': 'SUPPL ', 'submission_number': 15}

11,236

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U....

custom-source

2025-02-12T13:44:45.174083

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf', 'application_number': 18563, 'submission_type': 'SUPPL ', 'submission_number': 57}

11,237

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U....

custom-source

2025-02-12T13:44:45.208190

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf', 'application_number': 18564, 'submission_type': 'SUPPL ', 'submission_number': 59}

11,235

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U....

custom-source

2025-02-12T13:44:45.223246

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf', 'application_number': 18562, 'submission_type': 'SUPPL ', 'submission_number': 56}

11,241

Topicort® (Desoximetasone) Ointment USP 0.05% For topical use only. Not for oral, ophthalmic, or intravaginal use. Rx only DESCRIPTION Topicort® (desoximetasone) Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical co...

custom-source

2025-02-12T13:44:45.617773

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf', 'application_number': 18594, 'submission_type': 'SUPPL ', 'submission_number': 7}

11,240

FUROSEMIDE FUROSEMIDE INJECTION, USP INJECTION, USP 10 mg/mL 10 mg/mL Rx Only Rx Only bar code WARNING Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose sch...

custom-source

2025-02-12T13:44:45.619530

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf', 'application_number': 18579, 'submission_type': 'SUPPL ', 'submission_number': 29}

11,239

CII NDA 018565/S-020 Page 4 PRESERVATIVE-FREE DURAMORPH (morphine sulfate injection, USP) Rx only Not For Use in Continuous Microinfusion Devices DESCRIPTION Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the...

custom-source

2025-02-12T13:44:45.641458

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf', 'application_number': 18565, 'submission_type': 'SUPPL ', 'submission_number': 20}

11,238

1 PRESERVATIVE-FREE DURAMORPH (morphine sulfate injection, USP) CII Rx only DESCRIPTION Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the sulfate salt, having the following structural formula: 7,8-Didehydro-4,5-epoxy-17-methyl-(5Į,6Į)-morphinan-3,6-diol su...

custom-source

2025-02-12T13:44:45.658525

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf', 'application_number': 18565, 'submission_type': 'SUPPL ', 'submission_number': 14}

11,243

N18602/S-063 Page 2 CARDIZEM® (diltiazem hydrochloride) Direct Compression Tablets Rx only DESCRIPTION Cardizem® (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, dilt...

custom-source

2025-02-12T13:44:45.882164

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf', 'application_number': 18602, 'submission_type': 'SUPPL ', 'submission_number': 63}

11,244

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda

custom-source

2025-02-12T13:44:45.986443

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18609s33s35lbl.pdf', 'application_number': 18609, 'submission_type': 'SUPPL ', 'submission_number': 33}

11,242

Reference ID: 3186262 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3186262 This label may...

custom-source

2025-02-12T13:44:46.019245

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf', 'application_number': 18594, 'submission_type': 'SUPPL ', 'submission_number': 8}

11,245

Heparin Sodium and 0.9% Sodium Chloride Injection in Plastic Container VIAFLEX Plus Container DESCRIPTION Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in hepar...

custom-source

2025-02-12T13:44:46.048635

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf', 'application_number': 18609, 'submission_type': 'SUPPL ', 'submission_number': 44}

11,246

nicotine polacrilex gum, 2mg STOP SMOKING AID ® FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY If you smoke 25 or more cigarettes a day: use Nicorette 4mg 40 PIECES, 2mg EACH GUM GUM 2mg 2mg COATED COATED Drug Facts Active ingredient Purpose (in each chewing piece) Nicotine polacrilex (equal to 2mg...

custom-source

2025-02-12T13:44:46.453334

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf', 'application_number': 18612, 'submission_type': 'SUPPL ', 'submission_number': 42}

11,249

NDA 18-613/S-011 Page 3 3 OVIDE® (malathion) Lotion, 0.5% NDC 99207-650-02 Ovide® (malathion) Lotion, 0.5% Rx Only For topical use only. Not for oral or ophthalmic use. DESCRIPTION OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, d...

custom-source

2025-02-12T13:44:46.535657

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf', 'application_number': 18613, 'submission_type': 'SUPPL ', 'submission_number': 11}

11,250

company logo NDC 51672-5276-4 Ovide® (malathion) Lotion, 0.5% Rx Only For topical use only. Not for oral or ophthalmic use. DESCRIPTION OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isop...

custom-source

2025-02-12T13:44:46.780327

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf', 'application_number': 18613, 'submission_type': 'SUPPL ', 'submission_number': 17}

11,251

TRENTAL® (pentoxifylline) Extended-Release Tablets, 400 mg DESCRIPTION TRENTAL® (pentoxifylline) extended-release tablets for oral administration contain 400 mg of the active drug and the follo...

custom-source

2025-02-12T13:44:46.906064

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf', 'application_number': 18631, 'submission_type': 'SUPPL ', 'submission_number': 41}

11,248

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...

custom-source

2025-02-12T13:44:47.179612

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf', 'application_number': 18612, 'submission_type': 'SUPPL ', 'submission_number': 74}

11,252

Attachment 1 Page 1 Class Suicidality Labeling Language for Antidepressants [This section should be located at the beginning of the package insert with bolded font and enclosed in a black box] [Insert established name] Suicidality in Children and Adolescents Antidepressants increased the risk o...

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2025-02-12T13:44:47.323975

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 30}

11,247

0 0 0000-0000-00 Reference ID: 3522999 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3522999 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsat...

custom-source

2025-02-12T13:44:47.968196

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf', 'application_number': 18612, 'submission_type': 'SUPPL ', 'submission_number': 72}

11,253

1 PRESCRIBING INFORMATION 1 WELLBUTRIN® 2 (bupropion hydrochloride) 3 Tablets 4 5 Suicidality in Children and Adolescents 6 Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in 7 short-term studies in children and adolescents with Major Depressive Disorder (MDD) and ...

custom-source

2025-02-12T13:44:48.332920

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 33}

11,255

NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 4 PRESCRIBING INFORMATION WELLBUTRIN® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders: Antidepressants increa...

custom-source

2025-02-12T13:44:48.334464

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 39}

11,254

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 PRESCRIBING INFORMATION WELLBUTRIN® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Di...

custom-source

2025-02-12T13:44:48.498204

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 38}

11,256

PRESCRIBING INFORMATION WELLBUTRIN® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young ad...

custom-source

2025-02-12T13:44:48.759435

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 43}

11,258

NDA 18-651/S-018 Page 3 500012 3E Rev 10/2002 MARINOL® (Dronabinol) Capsules DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl- 6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas: ...

custom-source

2025-02-12T13:44:48.820156

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf', 'application_number': 18651, 'submission_type': 'SUPPL ', 'submission_number': 18}

11,259

NDA 18-651/S-021 Page 3 500012 Rev Sep 2004 MARINOL® (Dronabinol) Capsules DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas: Dro...

custom-source

2025-02-12T13:44:48.872854

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf', 'application_number': 18651, 'submission_type': 'SUPPL ', 'submission_number': 21}

11,257

...

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2025-02-12T13:44:49.068559

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf', 'application_number': 18644, 'submission_type': 'SUPPL ', 'submission_number': 46}

11,261

Locoid® (hydrocortisone butyrate) Ointment, 0.1% For topical use DESCRIPTION Locoid® (hydrocortisone butyrate) Ointment, 0.1% contains the topical corticosteroid, hydrocortisone bu...

custom-source

2025-02-12T13:44:49.116472

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf', 'application_number': 18652, 'submission_type': 'SUPPL ', 'submission_number': 10}

11,262

C:\Data\My Documents\Flagyl\Feb04proposed18657label.doc Last Saved On 03/04/04 6:37 PMBaxter Confidential Page 1 of 6 Metronidazole Injection, USP RTU® in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU and...

custom-source

2025-02-12T13:44:49.164398

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 27}

11,260

NDA 18-651/S-025 and S-026 Page 3 MARINOL® (dronabinol) Capsules DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas: Dronabinol, the activ...

custom-source

2025-02-12T13:44:49.201627

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf', 'application_number': 18651, 'submission_type': 'SUPPL ', 'submission_number': 26}

11,263

NDA 18-657/S-029 Page 5 *BAR CODE LOCATION ONLY 071959414 Baxter Metronidazole Injection, USP RTU® in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU® and...

custom-source

2025-02-12T13:44:49.461719

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 29}

11,265

Metronidazole Injection, USP in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP and other antibacterial drugs, Metronid...

custom-source

2025-02-12T13:44:49.591930

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 32}

11,264

NDA 018657/S-31 Page 3 Metronidazole Injection, USP RTU in Plastic Container VIAFLEX Plus Container To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU and other antibacterial drugs, Metronidazole Injection, USP RTU shoul...

custom-source

2025-02-12T13:44:49.837945

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf', 'application_number': 18657, 'submission_type': 'SUPPL ', 'submission_number': 31}

11,266

C I A 7 0 2 3 0 K Dextromethorphan Polistirex Extended-Release Suspension (Cough Suppressant) Contains No Fever Reducer or Pain Reliever 148 mL (5 fl oz) Alcohol-free Flavored Liquid Flavored Liquid FRONT LABEL 2 1/4" 2 7/8" 8137787 022014 NDC 63824-177-65 PT# C I A 60331 Reference ID: 3610277 (b) (4)...

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2025-02-12T13:44:50.006907

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf', 'application_number': 18658, 'submission_type': 'SUPPL ', 'submission_number': 30}

11,267

ACCUTANE® (isotretinoin) CAPSULES CAUSES BIRTH DEFECTS AVOID PREGNANCY CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result ...

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2025-02-12T13:44:50.150190

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 41}

11,268

ACCUTANE   (isotretinoin) CAPSULES CAUSES BIRTH DEFECTS DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can re...

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2025-02-12T13:44:50.256163

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 51}

11,269

3 NARRATION SCRIPT Revised 2/6/03 FLK100VID ACCUTANE PREGNANCY VIDEO Opening Segment “ACCUTANE® CANNOT BE TAKEN BY WOMEN WHO ARE PREGNANT, BECAUSE ACCUTANE CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. In this video we will see what can happen to an unborn baby if the baby’s mother takes Ac...

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2025-02-12T13:44:50.631979

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 52}

11,272

NDA 18-676/S-022 Page 5 Y36-002-487 PACKAGE INSERT HepatAmine® (8% Amino Acid Injection) Protect from light until use. DESCRIPTION Rx only HepatAmine (8% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 500 mL unit provides a total of 4...

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2025-02-12T13:44:50.777670

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf', 'application_number': 18676, 'submission_type': 'SUPPL ', 'submission_number': 22}

11,270

NDA 18-662/S054 Page 3 ACCUTANE (isotretinoin) CAPSULES Rx only CAUSES BIRTH DEFECTS DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extrem...

custom-source

2025-02-12T13:44:50.812734

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 54}

11,271

NDA 18-662/S-056 Page 11 ACCUTANE® (isotretinoin capsules) Rx only CAUSES BIRTH DEFECTS DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will r...

custom-source

2025-02-12T13:44:51.007416

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf', 'application_number': 18662, 'submission_type': 'SUPPL ', 'submission_number': 56}

11,273

To reduce the development of drug- resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Trimethoprim i...

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2025-02-12T13:44:51.180242

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf', 'application_number': 18679, 'submission_type': 'SUPPL ', 'submission_number': 40}

11,275

NDA 18-680/S-060 Page 3 PROPOSED PRESCRIBING INFORMATION ParaGard® T 380A Intrauterine Copper Contraceptive Prescribing Information Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. ParaGard® T 380A Intrauterine Co...

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2025-02-12T13:44:51.280569

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018680s060lbl.pdf', 'application_number': 18680, 'submission_type': 'SUPPL ', 'submission_number': 60}

11,276

NDA 18681/S-027 Page 5 LD-442-1 Y36-002-845 Package Insert Lactated Ringer's Irrigation FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES Not For Injection By Usual Parenteral Routes Flexible Irrigation Container Rx only DESCRIPTION Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of ...

custom-source

2025-02-12T13:44:51.333293

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf', 'application_number': 18681, 'submission_type': 'SUPPL ', 'submission_number': 27}

11,274

TRIMETHOPRIM TABLETS, USP 2158 Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are...

custom-source

2025-02-12T13:44:51.334845

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf', 'application_number': 18679, 'submission_type': 'SUPPL ', 'submission_number': 44}

11,277

PMS Black Last Time Saved: 12/1/2009 8:56 AM Document Name: QEN-2313v3.qxp Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pres...

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2025-02-12T13:44:51.560339

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf', 'application_number': 18692, 'submission_type': 'SUPPL ', 'submission_number': 14}

11,278

MarcaineTM Bupivacaine Hydrochloride Injection, USP MarcaineTM With Epinephrine 1:200,000 (as bitartrate) Bupivacaine Hydrochloride and Epinephrine Injection, USP Rx only DESCRIPTION Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohyd...

custom-source

2025-02-12T13:44:51.704079

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf', 'application_number': 18692, 'submission_type': 'SUPPL ', 'submission_number': 15}

11,279

structural formula HALDOL® Decanoate 50 (haloperidol) HALDOL® Decanoate 100 (haloperidol) For IM Injection Only WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an incr...

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2025-02-12T13:44:51.880685

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf', 'application_number': 18701, 'submission_type': 'SUPPL ', 'submission_number': 54}

11,280

HALDOL® brand of haloperidol injection (For Immediate Release) WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen pla...

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2025-02-12T13:44:51.883257

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf', 'application_number': 18701, 'submission_type': 'SUPPL ', 'submission_number': 59}

11,281

HALDOL brand of haloperidol injection (For Immediate Release) WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with...

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2025-02-12T13:44:52.044694

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf', 'application_number': 18701, 'submission_type': 'SUPPL ', 'submission_number': 72}

11,282

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda

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2025-02-12T13:44:52.117561

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf', 'application_number': 18702, 'submission_type': 'SUPPL ', 'submission_number': 7}

11,283

ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% ACLOVATE® (alclometasone dipropionate ointment) Ointment, 0.05% Rx only For Dermatologic Use Only– Not for Ophthalmic Use. DESCRIPTION ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% and ACLOVATE® (alclometasone dipropionat...

custom-source

2025-02-12T13:44:52.223538

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf', 'application_number': 18702, 'submission_type': 'SUPPL ', 'submission_number': 11}

11,284

1 PRESCRIBING INFORMATION 1 ZANTAC® 150 2 (ranitidine hydrochloride) 3 Tablets, USP 4 5 ZANTAC® 300 6 (ranitidine hydrochloride) 7 Tablets, USP 8 9 ZANTAC® 25 10 (ranitidine hydrochloride effervescent) 11 EFFERdose® Tablets 12 13 ZANTAC® 150 14 (ranitidine hydrochloride effervescen...

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2025-02-12T13:44:52.319658

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf', 'application_number': 18703, 'submission_type': 'SUPPL ', 'submission_number': 65}

11,286

PRESCRIBING INFORMATION ZANTAC® 150 (ranitidine hydrochloride) Tablets, USP ZANTAC® 300 (ranitidine hydrochloride) Tablets, USP ZANTAC® 25 (ranitidine hydrochloride effervescent) EFFERdose® Tablets ZANTAC® (ranitidine hydrochloride) Syrup, USP DESCRIPTION...

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2025-02-12T13:44:52.384544

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf', 'application_number': 18703, 'submission_type': 'SUPPL ', 'submission_number': 68}

11,285

PRESCRIBING INFORMATION ZANTAC® 150 (ranitidine hydrochloride) Tablets, USP ZANTAC® 300 (ranitidine hydrochloride) Tablets, USP ZANTAC® 25 (ranitidine hydrochloride effervescent) EFFERdose® Tablets ZANTAC® (ranitidine hydrochloride) Syrup, USP DESCRIPTION...

custom-source

2025-02-12T13:44:52.418743

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf', 'application_number': 18703, 'submission_type': 'SUPPL ', 'submission_number': 67}

11,287

NDA 017963/S-063 NDA 018704/S-023 Page 4 Lopressor® metoprolol tartrate tablets, USP metoprolol tartrate injection, USP Rx only Prescribing Information DESCRIPTION Lopressor, metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, avail...

custom-source

2025-02-12T13:44:52.546346

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf', 'application_number': 18704, 'submission_type': 'SUPPL ', 'submission_number': 23}