HenriLD/FDA_Docs · Datasets at Hugging Face

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12,163	s truct ura l formula PENTASA® (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of July 2013 Rx only DESCRIPTION PENTASA (mesalamine) for oral administration is a controlled-release formulation of mesalamine, an aminosalicylate anti-inflammator...	custom-source	2025-02-12T13:46:33.563232	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf', 'application_number': 20049, 'submission_type': 'SUPPL ', 'submission_number': 26}
12,166	DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. EXP LOT DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. 0.5 FL OZ (15 mL) www.bausch.com With antihistamine to relieve itching Original prescription strength Allergy When using this product ■ overuse may cause more eye redness ■ pupils may become enlarged temporar...	custom-source	2025-02-12T13:46:33.889194	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf', 'application_number': 20065, 'submission_type': 'SUPPL ', 'submission_number': 17}
12,167		custom-source	2025-02-12T13:46:33.921748	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_prntlbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 10}
12,171	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	2025-02-12T13:46:35.533059	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 54}
12,170	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	2025-02-12T13:46:37.123334	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 49}
12,172	1 1 EC-NAPROSYN® (naproxen delayed-release tablets) 2 NAPROSYN® (naproxen tablets) 3 ANAPROX®/ANAPROX®DS (naproxen sodium tablets) 4 NAPROSYN®(naproxen suspension) 5 Rx only 6 7 8 9 DESCRIPTION 10 Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory 11 d...	custom-source	2025-02-12T13:46:38.315739	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 4}
12,169	Reference ID: 3159401 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3159401 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: ...	custom-source	2025-02-12T13:46:38.533823	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 46}
12,173	NDA 17-581/S-106, 18-164/S-056, 18-965/S-014, 20-067/S-011 Page 3 EC-NAPROSYN® (naproxen delayed-release tablets) NAPROSYN® (naproxen tablets) ANAPROX®/ANAPROX® DS (naproxen sodium tablets) NAPROSYN® (naproxen suspension) Rx only Cardiovascular Risk • NSAIDs may cause an increased risk of serious car...	custom-source	2025-02-12T13:46:39.321865	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 11}
12,168	Reference ID: 3084533 Reference ID: 3087459 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3084533 Reference ID: 3087459 This label may not be the latest approved by FDA. For current labeling information, please visit ht...	custom-source	2025-02-12T13:46:39.505196	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 42}
12,175	1 2 EC-NAPROSYN® (naproxen delayed-release tablets) 3 NAPROSYN® (naproxen tablets) 4 ANAPROX®/ANAPROX® DS (naproxen sodium tablets) 5 NAPROSYN® (naproxen suspension) Roche Logo 6 Rx only Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic even...	custom-source	2025-02-12T13:46:39.613457	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 17}
12,174	(RoChe) EC-NAPROSYN~ (naproxen delayed-release tablets) NAPROSYN~ (naproxen tablets) ANAPROX~/ANAPROX~ DS (naproxen sodium tablets) NAPROSYN~ (naproxen suspension) Rx only Cardiovascular Risk . NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can b...	custom-source	2025-02-12T13:46:39.825571	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 14}
12,176	EC-NAPROSYN (naproxen delayed-release tablets) NAPROSYN (naproxen tablets) ANAPROX/ANAPROX DS (naproxen sodium tablets) NAPROSYN (naproxen suspension) Rx only Cardiovascular Risk  NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can b...	custom-source	2025-02-12T13:46:39.870295	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 18}
12,177	NDA 20068/S-20 FOSCAVIR ® (foscarnet sodium) INJECTION WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF FOSCAVIR. FREQUENT MONITORING OF SERUM CREATININE, WITH DOSE ADJUSTMENT FOR CHANGES IN ...	custom-source	2025-02-12T13:46:39.973774	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf', 'application_number': 20068, 'submission_type': 'SUPPL ', 'submission_number': 20}
12,179	NDA 20-073/S-016 Page 3 ROMAZICON® (flumazenil) INJECTION Rx only DESCRIPTION ROMAZICON® (flumazenil) is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepi...	custom-source	2025-02-12T13:46:40.153835	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf', 'application_number': 20073, 'submission_type': 'SUPPL ', 'submission_number': 16}
12,178	1 Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Desogen® (desogestrel and ethinyl estradiol) Tablets provide an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel ...	custom-source	2025-02-12T13:46:40.252829	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf', 'application_number': 20071, 'submission_type': 'SUPPL ', 'submission_number': 17}
12,181	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	2025-02-12T13:46:40.316242	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 21}
12,180	LIORESAL® INTRATHECAL (baclofen injection) Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabd...	custom-source	2025-02-12T13:46:40.446466	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf', 'application_number': 20075, 'submission_type': 'SUPPL ', 'submission_number': 24}
12,182	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	2025-02-12T13:46:40.614808	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 36}
12,183	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	2025-02-12T13:46:40.652946	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 41}
12,184	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	2025-02-12T13:46:40.718736	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 42}
12,185	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	2025-02-12T13:46:40.839102	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 43}
12,186	NDA 20-080/S-036 Package Insert Page 1 of 24 1 PRESCRIBING INFORMATION 1 IMITREX® 2 (sumatriptan succinate) 3 Injection 4 5 For Subcutaneous Use Only. 6 DESCRIPTION 7 IMITREX (sumatriptan succinate) Injection is a selective 5-hydroxytryptamine1 receptor 8 subtype agonist. Sumatriptan succinat...	custom-source	2025-02-12T13:46:41.035879	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 36}
12,188	...	custom-source	2025-02-12T13:46:41.244424	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 41}
12,187	...	custom-source	2025-02-12T13:46:41.401460	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 40}
12,189	...	custom-source	2025-02-12T13:46:41.495250	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 48}
12,190	Hepatotoxicity Labeling -062602 1 JANSSEN PHARMACEUTICA PRODUCTS, L.P. SPORANOX  (ITRACONAZOLE) CAPSULES Congestive Heart Failure SPORANOX  (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failur...	custom-source	2025-02-12T13:46:41.647999	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 28}
12,192	Hepatotoxicity Labeling -062602 1 JANSSEN PHARMACEUTICA PRODUCTS, L.P. SPORANOX  (ITRACONAZOLE) CAPSULES Congestive Heart Failure SPORANOX  (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failur...	custom-source	2025-02-12T13:46:41.767623	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 31}
12,191	SPORANOX PPI Janssen proposal March 26, 2002 Patient Information 1 March 26, 2002 2 SPORANOX® 3 (itraconazole) Capsules 4 strikeout=deleted 5 double underline=added 6 7 This summary contains important information about SPORANOX (SPOR-ah-nox). This 8 information is for patients who have been prescribed SP...	custom-source	2025-02-12T13:46:41.789778	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 29}
12,193	CBE-January 2004 1 JANSSEN PHARMACEUTICA PRODUCTS, L.P. SPORANOX (ITRACONAZOLE) CAPSULES Congestive Heart Failure SPORANOX (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure...	custom-source	2025-02-12T13:46:41.951797	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 35}
12,194	SPORANOX® (itraconazole) Capsules Congestive Heart Failure: SPORANOX® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a h...	custom-source	2025-02-12T13:46:42.244478	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 40}
12,195	SPORANOX® (itraconazole) Capsules Congestive Heart Failure: SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms ...	custom-source	2025-02-12T13:46:42.421791	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 46}
12,196	structural formula SPORANOX® (itraconazole) Capsules Congestive Heart Failure, Cardiac Effects and Drug Interactions: SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure ...	custom-source	2025-02-12T13:46:42.579005	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 48}
12,197	structural formula SPORANOX® (itraconazole) Capsules Congestive Heart Failure, Cardiac Effects and Drug Interactions: SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure ...	custom-source	2025-02-12T13:46:42.628481	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 50}
12,199	NDA 18-828/S-026, S-027 NDA 19-909/S-016, S-017 NDA 20-089/S-015, S-016 Page 3 PRODUCT INFORMATION ZOVIRAX® (acyclovir) Capsules ZOVIRAX® (acyclovir) Tablets ZOVIRAX® (acyclovir) Suspension DESCRIPTION: ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Capsul...	custom-source	2025-02-12T13:46:42.710198	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf', 'application_number': 20089, 'submission_type': 'SUPPL ', 'submission_number': 16}
12,200	NDA 18-828/SLR-029 NDA 19-909/SLR-019 NDA 20-089/SLR-018 Page 3 PRESCRIBING INFORMATION ZOVIRAX® (acyclovir) Capsules ZOVIRAX® (acyclovir) Tablets ZOVIRAX® (acyclovir) Suspension DESCRIPTION ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against ...	custom-source	2025-02-12T13:46:42.812966	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf', 'application_number': 20089, 'submission_type': 'SUPPL ', 'submission_number': 18}
12,201	DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension and as a st...	custom-source	2025-02-12T13:46:42.886910	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 12}
12,203	1 23-4526-00-1 PATIENT INFORMATION DIFLUCAN (fluconazole tablets) This leaflet contains important information about DIFLUCAN (dye-FLEW-kan). It is not meant to take the place of your doctor's instructions. Read this information carefully before you take DIFLUCAN. Ask your doctor or pharmacist if you do no...	custom-source	2025-02-12T13:46:43.031390	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 19}
12,202	1 PATIENT INFORMATION DIFLUCAN (fluconazole tablets) This leaflet contains important information about DIFLUCAN (dye-FLEW-kan). It is not meant to take the place of your doctor's instructions. Read this information carefully before you take DIFLUCAN. Ask your doctor or pharmacist if you do not understand any of this i...	custom-source	2025-02-12T13:46:43.125494	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 15}
12,198	SPORANOX® (itraconazole) Capsules BOXED WARNING Congestive Heart Failure, Cardiac Effects and Drug Interactions: SPORANOX® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a histo...	custom-source	2025-02-12T13:46:43.207193	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 53}
12,204	DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral admin...	custom-source	2025-02-12T13:46:43.297615	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 22}
12,205	DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral admin...	custom-source	2025-02-12T13:46:43.394298	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 31}
12,208	s t ruc tur al f or mu la DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® ...	custom-source	2025-02-12T13:46:43.662170	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 42}
12,206	DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral adminis...	custom-source	2025-02-12T13:46:43.773105	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020090s034lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 34}
12,207	s t ruc tur al f or mu la DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as ...	custom-source	2025-02-12T13:46:44.002033	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 38}
12,209	s t ruc tur al f or mu la DIFLUCAN® (Fluconazole Tablets) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole a...	custom-source	2025-02-12T13:46:44.054583	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 44}
12,213	1 1 2 3 4 5 PV 5324 DPP PROZAC® FLUOXETINE CAPSULES, USP FLUOXETINE ORAL SOLUTION, USP FLUOXETINE DELAYED-RELEASE CAPSULES, USP WARNING 6 Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to 7 placebo of suicidal thinking and behavior (suicidality) in children, adolescent...	custom-source	2025-02-12T13:46:44.484531	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf', 'application_number': 20101, 'submission_type': 'SUPPL ', 'submission_number': 37}
12,214	1 PV 5326 DPP 1 PROZAC® 2 FLUOXETINE CAPSULES, USP 3 FLUOXETINE ORAL SOLUTION, USP 4 FLUOXETINE DELAYED-RELEASE CAPSULES, USP 5 WARNING 6 Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to 7 placebo of suicidal thinking and behavior (suicidality) in children, adolescen...	custom-source	2025-02-12T13:46:44.486115	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf', 'application_number': 20101, 'submission_type': 'SUPPL ', 'submission_number': 39}
12,210	MIVACRON® Injection (mivacurium chloride) This drug should be administered only by adequately trained individuals familiar with its actions, characteristics, and hazards. DESCRIPTION MIVACRON (mivacurium chloride) is a short-acting, ...	custom-source	2025-02-12T13:46:44.673522	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020098s018lbl.pdf', 'application_number': 20098, 'submission_type': 'SUPPL ', 'submission_number': 18}
12,212	1 PV 5321 DPP PROZAC® FLUOXETINE CAPSULES, USP FLUOXETINE ORAL SOLUTION, USP WARNING Suicidality in Children and Adolescents — Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psyc...	custom-source	2025-02-12T13:46:45.049731	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf', 'application_number': 20101, 'submission_type': 'SUPPL ', 'submission_number': 35}
12,216	PRESCRIBING INFORMATION ZOFRAN® (ondansetron hydrochloride) Tablets ZOFRAN ODT® (ondansetron) Orally Disintegrating Tablets ZOFRAN® (ondansetron hydrochloride) Oral Solution DESCRIPTION The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate...	custom-source	2025-02-12T13:46:45.191547	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 27}
12,218	structural formula PRESCRIBING INFORMATION ZOFRAN® (ondansetron hydrochloride) Tablets ZOFRAN ODT® (ondansetron) Orally Disintegrating Tablets ZOFRAN® (ondansetron hydrochloride) Oral Solution DESCRIPTION The active ingredient in ZOFRAN Tablets and ZOFRAN Oral S...	custom-source	2025-02-12T13:46:45.258508	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 30}
12,217	PRESCRIBING INFORMATION ZOFRAN® (ondansetron hydrochloride) Tablets ZOFRAN ODT® (ondansetron) Orally Disintegrating Tablets ZOFRAN® (ondansetron hydrochloride) Oral Solution DESCRIPTION The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hyd...	custom-source	2025-02-12T13:46:45.263422	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 29}
12,219	1 2 PRESCRIBING INFORMATION 3 ZOFRAN® 4 (ondansetron hydrochloride) 5 Tablets 6 7 ZOFRAN ODT® 8 (ondansetron) 9 Orally Disintegrating Tablets 10 11 ...	custom-source	2025-02-12T13:46:45.481258	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 34}
12,220	Xttrium Laboratories, Inc. Confidential Page 24 of 24 Chlorhexidine Gluconate 0.75% Solution Section 1.14.1-Draft Labeling Amendment to NDA 20-111/ -Revision Request Attachment # 1: NDA 20-111 -Revised labeling, 4-ounce Dyna-Hex 0.75% CHG Reference ...	custom-source	2025-02-12T13:46:45.520327	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020111Orig1s007lbl.pdf', 'application_number': 20111, 'submission_type': 'SUPPL ', 'submission_number': 7}
12,222	1 SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants are: Molecular weight 168.04 ...	custom-source	2025-02-12T13:46:45.659128	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s012lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 12}
12,221	NDA 20-118/S-010 Page 3 SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants are: Mole...	custom-source	2025-02-12T13:46:45.694858	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s010lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 10}
12,223	SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants ar...	custom-source	2025-02-12T13:46:45.896006	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020118s016lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 16}
12,224	_______________________________________________________________________________________________________________________________ ...	custom-source	2025-02-12T13:46:46.085429	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020118s017lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 17}
12,226	Muro Pharmaceutical, Inc. Tri-Nasal Spray ® NDA #20-120 Amendment Page 1 ))))))))))))))))))))))))))))))))))))))))))) D R A F T TRI-NASAL SPRAY (triamcinolone ® acetonide nasal spray, 50 mcg) For Intranasal Use Only DESCRIPTION: Triamcinolone acetonide, the active ingredient of Tri-Nasal Spray, is a corticosteroid ...	custom-source	2025-02-12T13:46:46.093833	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20120lbl.pdf', 'application_number': 20120, 'submission_type': 'ORIG ', 'submission_number': 1}
12,225	VUMON® (teniposide injection) WARNING VUMON (teniposide injection) is a cytotoxic drug which should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when ...	custom-source	2025-02-12T13:46:46.114961	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf', 'application_number': 20119, 'submission_type': 'SUPPL ', 'submission_number': 11}
12,227	DESCRIPTION Triamcinolone acetonide, the active ingredient of AllerNaze, is a corticosteroid with the chemical name, 9α-Fluoro-11β,16α, 17, 21 tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone (C24 H31 FO6 ). Its structural formula is: Structural Formula Triamcinolone acetoni...	custom-source	2025-02-12T13:46:46.331088	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020120s002lbl.pdf', 'application_number': 20120, 'submission_type': 'SUPPL ', 'submission_number': 2}
12,228		custom-source	2025-02-12T13:46:46.473767	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf', 'application_number': 20121, 'submission_type': 'SUPPL ', 'submission_number': 9}
12,230	...	custom-source	2025-02-12T13:46:46.771833	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf', 'application_number': 20121, 'submission_type': 'SUPPL ', 'submission_number': 44}
12,229	PRESCRIBING INFORMATION 1 FLONASE® 2 (fluticasone propionate) 3 Nasal Spray, 50 mcg 4 SHAKE GENTLY 5 For Intranasal Use Only. BEFORE USE. 6 DESCRIPTION 7 Fluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic 8 corticosteroid having the chemical name S-(fluoromethyl...	custom-source	2025-02-12T13:46:46.863569	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf', 'application_number': 20121, 'submission_type': 'SUPPL ', 'submission_number': 30}
12,231	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all of the information needed to use OMNISCAN safely and effectively. See fulI prescribing information for OMNISCAN. OMNISCAN™ (gadodiamide) Injection for Intravenons Use Initial U.S. Approval: 1993 WARNING: NOT FOR INTRATHECAL USE and NEPHROGENIC SY...	custom-source	2025-02-12T13:46:46.915367	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf', 'application_number': 20123, 'submission_type': 'SUPPL ', 'submission_number': 35}
12,232	_______________________________________________________________________________________________________________________________________ ...	custom-source	2025-02-12T13:46:46.997112	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020123s037lbl.pdf', 'application_number': 20123, 'submission_type': 'SUPPL ', 'submission_number': 37}
12,234	ACCURETIC™ (quinapril HCl/hydrochlorothiazide) Tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACCURETIC should be discontinued as soon as possible. See ...	custom-source	2025-02-12T13:46:47.306456	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 7}
12,235	ACCURETIC™ (quinapril HCl/hydrochlorothiazide) Tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACCURETIC should be discontinued as soon as possible. See WARNINGS:...	custom-source	2025-02-12T13:46:47.452661	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 10}
12,233	...	custom-source	2025-02-12T13:46:47.532685	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf', 'application_number': 20123, 'submission_type': 'SUPPL ', 'submission_number': 39}
12,236	ACCURETIC (quinapril HCl/hydrochlorothiazide) Tablets WARNING: FETAL TOXICITY  When pregnancy is detected, discontinue ACCURETIC as soon as possible.  Drugs that act ...	custom-source	2025-02-12T13:46:47.689921	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 18}
12,237	ACCURETIC (quinapril HCl/hydrochlorothiazide) Tablets WARNING: FETAL TOXICITY  When pregnancy is detected, discontinue ACCURETIC 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...	custom-source	2025-02-12T13:46:47.806591	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 20}
12,239	NDA 21-276 Final Labeling June 29, 2001 1 ESTROSTEP® (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP) ESTROSTEP® 21 (Each white triangular tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each white square tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each wh...	custom-source	2025-02-12T13:46:48.089623	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf', 'application_number': 20130, 'submission_type': 'SUPPL ', 'submission_number': 7}
12,238	ZONALON® (doxepin hydrochloride) CREAM, 5% FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. DESCRIPTION Zonalon (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride is one of a...	custom-source	2025-02-12T13:46:48.209490	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf', 'application_number': 20126, 'submission_type': 'SUPPL ', 'submission_number': 6}
12,241	ProHance® (Gadoteridol) Injection, 279.3 mg/mL WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not availabl...	custom-source	2025-02-12T13:46:48.233967	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf', 'application_number': 20131, 'submission_type': 'SUPPL ', 'submission_number': 26}
12,240	ProHance(8 Multipack™ (Gadoteridol) Injection, 279.3 mg/mL Pharmacy Bulk Package -...Page 1 of9 Prohance Multipack (gadoteridol) Injection, Solution (Bracco Diagnostics Inc. i Pharmacy Bulk Package - Not for Direct Infusion WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for ne...	custom-source	2025-02-12T13:46:48.354969	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf', 'application_number': 20131, 'submission_type': 'SUPPL ', 'submission_number': 23}
12,243	NDA 20136/S-023 Page 3 Demadex (torsemide) Tablets DESCRIPTION Demadex (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1 isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is: Structural Formula Its em...	custom-source	2025-02-12T13:46:48.508284	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020136s023lbl.pdf', 'application_number': 20136, 'submission_type': 'SUPPL ', 'submission_number': 23}
12,244	1 2 DEMADEX 3 (torsemide) 4 TABLETS 5 IN-0455-0X Rev. 08/12 6 DESCRIPTION 7 DEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical 8 name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula 9 is: structural formula 10 11 I...	custom-source	2025-02-12T13:46:48.804723	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020136s014lbl.pdf', 'application_number': 20136, 'submission_type': 'SUPPL ', 'submission_number': 24}
12,245	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Levoleucovorin safely and effectively. See full prescribing information for Levoleucovorin. Levoleucovorin (for Injection) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAVENOUS use Initial U.S. Approva...	custom-source	2025-02-12T13:46:48.854324	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf', 'application_number': 20140, 'submission_type': 'ORIG ', 'submission_number': 1}
12,242	1 PRESCRIBING INFORMATION 2 IMITREX® 3 (sumatriptan succinate) 4 Tablets 5 DESCRIPTION 6 IMITREX Tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 7 receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2 8 (dimethylamino)e...	custom-source	2025-02-12T13:46:48.968210	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf', 'application_number': 20132, 'submission_type': 'SUPPL ', 'submission_number': 20}
12,246	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fusilev safely and ...	custom-source	2025-02-12T13:46:48.977041	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf', 'application_number': 20140, 'submission_type': 'SUPPL ', 'submission_number': 1}
12,247	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information...	custom-source	2025-02-12T13:46:49.442616	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf', 'application_number': 20140, 'submission_type': 'SUPPL ', 'submission_number': 2}
12,248	structural formula company logo Cataflam® (diclofenac potassium immediate-release tablets) Tablets of 50 mg Rx only Prescribing Information CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fat...	custom-source	2025-02-12T13:46:49.492101	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf', 'application_number': 20142, 'submission_type': 'SUPPL ', 'submission_number': 21}
12,249	structural formula company logo Cataflam® (diclofenac potassium immediate-release tablets) Tablets of 50 mg Rx only Prescribing Information CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fat...	custom-source	2025-02-12T13:46:49.555025	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf', 'application_number': 20142, 'submission_type': 'SUPPL ', 'submission_number': 22}
12,250	N5-929 S-032 S-033 Package Insert Page 1 T2001-89 89014801 D.H.E. 45® (dihydroergotamine mesylate) Injection, USP Rx only Prescribing Information WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibito...	custom-source	2025-02-12T13:46:49.665634	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf', 'application_number': 20148, 'submission_type': 'SUPPL ', 'submission_number': 7}
12,251	Effexor Relapse/Recurrence CONFIDENTIAL 1 16 Mar 01 Effexor  (venlafaxine hydrochloride) Tablets DESCRIPTION Effexor (venlafaxine hydrochloride) is a structurally novel antidepressant for oral administration. It is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. It is designa...	custom-source	2025-02-12T13:46:50.509697	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 17}
12,253	1 Effexor (venlafaxine hydrochloride) Tablets only This product’s label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. DESCRIPTION Effe...	custom-source	2025-02-12T13:46:50.872519	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 32}
12,252	1 Effexor (venlafaxine hydrochloride) Tablets only This product’s label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. DESCRIPTION Effe...	custom-source	2025-02-12T13:46:50.931555	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 30}
12,254	1 Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality in Children and Adolescents Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short- term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering ...	custom-source	2025-02-12T13:46:51.285791	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 33}
12,255	Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) ...	custom-source	2025-02-12T13:46:51.369626	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 54}
12,256	Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and o...	custom-source	2025-02-12T13:46:51.918723	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 55}
12,257	Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) ...	custom-source	2025-02-12T13:46:51.978796	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 57}
12,258	Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and o...	custom-source	2025-02-12T13:46:52.086036	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 58}
12,259	Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychia...	custom-source	2025-02-12T13:46:52.170691	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf', 'application_number': 20151, 'submission_type': 'SUPPL ', 'submission_number': 59}
12,260	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 of ...	custom-source	2025-02-12T13:46:52.243327	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20152s035lbl.pdf', 'application_number': 20152, 'submission_type': 'SUPPL ', 'submission_number': 35}
12,262	ApprovletS037.doc (clean copy 27March02) Page 4 of 39 Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AN...	custom-source	2025-02-12T13:46:52.731851	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf', 'application_number': 20154, 'submission_type': 'SUPPL ', 'submission_number': 37}
12,263	Page 4 of 39 Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED ...	custom-source	2025-02-12T13:46:53.004644	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf', 'application_number': 20154, 'submission_type': 'SUPPL ', 'submission_number': 41}
12,264	January 27, 2003 Page 4 of 70 VDXribaJan03FDA.doc (clean) Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING ...	custom-source	2025-02-12T13:46:53.416756	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf', 'application_number': 20154, 'submission_type': 'SUPPL ', 'submission_number': 42}
12,265	NDA 20-154/S-044 NDA 20-155/S-034 NDA 20-156/S-035 NDA 21-183/S-010 Page 3 Rx only VIDEX EC (didanosine) VIDEX EC (didanosine) Delayed-Release Capsules Enteric-Coated Beadlets (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH DIDANOSINE...	custom-source	2025-02-12T13:46:53.492821	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf', 'application_number': 20154, 'submission_type': 'SUPPL ', 'submission_number': 44}
12,267	NDA 20-154/S-050 NDA 20-155/S-039 NDA 20-156/S-040 NDA 21-183/S-016 Page 5 of 72 Rx only VIDEX® (didanosine) VIDEX® (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN...	custom-source	2025-02-12T13:46:53.686294	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf', 'application_number': 20154, 'submission_type': 'SUPPL ', 'submission_number': 50}
12,270	Page 4 of 39 Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED ...	custom-source	2025-02-12T13:46:53.848227	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf', 'application_number': 20155, 'submission_type': 'SUPPL ', 'submission_number': 30}

12,163

s truct ura l formula PENTASA® (mesalamine) Controlled-Release Capsules 250 mg and 500 mg Prescribing Information as of July 2013 Rx only DESCRIPTION PENTASA (mesalamine) for oral administration is a controlled-release formulation of mesalamine, an aminosalicylate anti-inflammator...

custom-source

2025-02-12T13:46:33.563232

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf', 'application_number': 20049, 'submission_type': 'SUPPL ', 'submission_number': 26}

12,166

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. EXP LOT DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. 0.5 FL OZ (15 mL) www.bausch.com With antihistamine to relieve itching Original prescription strength Allergy When using this product ■ overuse may cause more eye redness ■ pupils may become enlarged temporar...

custom-source

2025-02-12T13:46:33.889194

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf', 'application_number': 20065, 'submission_type': 'SUPPL ', 'submission_number': 17}

12,167

custom-source

2025-02-12T13:46:33.921748

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_prntlbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 10}

12,171

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

2025-02-12T13:46:35.533059

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 54}

12,170

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

2025-02-12T13:46:37.123334

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 49}

12,172

1 1 EC-NAPROSYN® (naproxen delayed-release tablets) 2 NAPROSYN® (naproxen tablets) 3 ANAPROX®/ANAPROX®DS (naproxen sodium tablets) 4 NAPROSYN®(naproxen suspension) 5 Rx only 6 7 8 9 DESCRIPTION 10 Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory 11 d...

custom-source

2025-02-12T13:46:38.315739

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 4}

12,169

Reference ID: 3159401 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3159401 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: ...

custom-source

2025-02-12T13:46:38.533823

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 46}

12,173

NDA 17-581/S-106, 18-164/S-056, 18-965/S-014, 20-067/S-011 Page 3 EC-NAPROSYN® (naproxen delayed-release tablets) NAPROSYN® (naproxen tablets) ANAPROX®/ANAPROX® DS (naproxen sodium tablets) NAPROSYN® (naproxen suspension) Rx only Cardiovascular Risk • NSAIDs may cause an increased risk of serious car...

custom-source

2025-02-12T13:46:39.321865

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 11}

12,168

Reference ID: 3084533 Reference ID: 3087459 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda Reference ID: 3084533 Reference ID: 3087459 This label may not be the latest approved by FDA. For current labeling information, please visit ht...

custom-source

2025-02-12T13:46:39.505196

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf', 'application_number': 20066, 'submission_type': 'SUPPL ', 'submission_number': 42}

12,175

1 2 EC-NAPROSYN® (naproxen delayed-release tablets) 3 NAPROSYN® (naproxen tablets) 4 ANAPROX®/ANAPROX® DS (naproxen sodium tablets) 5 NAPROSYN® (naproxen suspension) Roche Logo 6 Rx only Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic even...

custom-source

2025-02-12T13:46:39.613457

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 17}

12,174

(RoChe) EC-NAPROSYN~ (naproxen delayed-release tablets) NAPROSYN~ (naproxen tablets) ANAPROX~/ANAPROX~ DS (naproxen sodium tablets) NAPROSYN~ (naproxen suspension) Rx only Cardiovascular Risk . NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can b...

custom-source

2025-02-12T13:46:39.825571

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 14}

12,176

EC-NAPROSYN (naproxen delayed-release tablets) NAPROSYN (naproxen tablets) ANAPROX/ANAPROX DS (naproxen sodium tablets) NAPROSYN (naproxen suspension) Rx only Cardiovascular Risk  NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can b...

custom-source

2025-02-12T13:46:39.870295

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 18}

12,177

NDA 20068/S-20 FOSCAVIR ® (foscarnet sodium) INJECTION WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF FOSCAVIR. FREQUENT MONITORING OF SERUM CREATININE, WITH DOSE ADJUSTMENT FOR CHANGES IN ...

custom-source

2025-02-12T13:46:39.973774

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf', 'application_number': 20068, 'submission_type': 'SUPPL ', 'submission_number': 20}

12,179

NDA 20-073/S-016 Page 3 ROMAZICON® (flumazenil) INJECTION Rx only DESCRIPTION ROMAZICON® (flumazenil) is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepi...

custom-source

2025-02-12T13:46:40.153835

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf', 'application_number': 20073, 'submission_type': 'SUPPL ', 'submission_number': 16}

12,178

1 Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Desogen® (desogestrel and ethinyl estradiol) Tablets provide an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel ...

custom-source

2025-02-12T13:46:40.252829

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf', 'application_number': 20071, 'submission_type': 'SUPPL ', 'submission_number': 17}

12,181

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

2025-02-12T13:46:40.316242

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 21}

12,180

LIORESAL® INTRATHECAL (baclofen injection) Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabd...

custom-source

2025-02-12T13:46:40.446466

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf', 'application_number': 20075, 'submission_type': 'SUPPL ', 'submission_number': 24}

12,182

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

2025-02-12T13:46:40.614808

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 36}

12,183

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

2025-02-12T13:46:40.652946

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 41}

12,184

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

2025-02-12T13:46:40.718736

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 42}

12,185

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

2025-02-12T13:46:40.839102

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf', 'application_number': 20076, 'submission_type': 'SUPPL ', 'submission_number': 43}

12,186

NDA 20-080/S-036 Package Insert Page 1 of 24 1 PRESCRIBING INFORMATION 1 IMITREX® 2 (sumatriptan succinate) 3 Injection 4 5 For Subcutaneous Use Only. 6 DESCRIPTION 7 IMITREX (sumatriptan succinate) Injection is a selective 5-hydroxytryptamine1 receptor 8 subtype agonist. Sumatriptan succinat...

custom-source

2025-02-12T13:46:41.035879

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 36}

12,188

...

custom-source

2025-02-12T13:46:41.244424

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 41}

12,187

...

custom-source

2025-02-12T13:46:41.401460

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 40}

12,189

...

custom-source

2025-02-12T13:46:41.495250

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf', 'application_number': 20080, 'submission_type': 'SUPPL ', 'submission_number': 48}

12,190

Hepatotoxicity Labeling -062602 1 JANSSEN PHARMACEUTICA PRODUCTS, L.P. SPORANOX  (ITRACONAZOLE) CAPSULES Congestive Heart Failure SPORANOX  (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failur...

custom-source

2025-02-12T13:46:41.647999

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 28}

12,192

Hepatotoxicity Labeling -062602 1 JANSSEN PHARMACEUTICA PRODUCTS, L.P. SPORANOX  (ITRACONAZOLE) CAPSULES Congestive Heart Failure SPORANOX  (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failur...

custom-source

2025-02-12T13:46:41.767623

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 31}

12,191

SPORANOX PPI Janssen proposal March 26, 2002 Patient Information 1 March 26, 2002 2 SPORANOX® 3 (itraconazole) Capsules 4 strikeout=deleted 5 double underline=added 6 7 This summary contains important information about SPORANOX (SPOR-ah-nox). This 8 information is for patients who have been prescribed SP...

custom-source

2025-02-12T13:46:41.789778

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 29}

12,193

CBE-January 2004 1 JANSSEN PHARMACEUTICA PRODUCTS, L.P. SPORANOX (ITRACONAZOLE) CAPSULES Congestive Heart Failure SPORANOX (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure...

custom-source

2025-02-12T13:46:41.951797

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 35}

12,194

SPORANOX® (itraconazole) Capsules Congestive Heart Failure: SPORANOX® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a h...

custom-source

2025-02-12T13:46:42.244478

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 40}

12,195

SPORANOX® (itraconazole) Capsules Congestive Heart Failure: SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms ...

custom-source

2025-02-12T13:46:42.421791

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 46}

12,196

structural formula SPORANOX® (itraconazole) Capsules Congestive Heart Failure, Cardiac Effects and Drug Interactions: SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure ...

custom-source

2025-02-12T13:46:42.579005

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 48}

12,197

structural formula SPORANOX® (itraconazole) Capsules Congestive Heart Failure, Cardiac Effects and Drug Interactions: SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure ...

custom-source

2025-02-12T13:46:42.628481

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 50}

12,199

NDA 18-828/S-026, S-027 NDA 19-909/S-016, S-017 NDA 20-089/S-015, S-016 Page 3 PRODUCT INFORMATION ZOVIRAX® (acyclovir) Capsules ZOVIRAX® (acyclovir) Tablets ZOVIRAX® (acyclovir) Suspension DESCRIPTION: ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Capsul...

custom-source

2025-02-12T13:46:42.710198

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf', 'application_number': 20089, 'submission_type': 'SUPPL ', 'submission_number': 16}

12,200

NDA 18-828/SLR-029 NDA 19-909/SLR-019 NDA 20-089/SLR-018 Page 3 PRESCRIBING INFORMATION ZOVIRAX® (acyclovir) Capsules ZOVIRAX® (acyclovir) Tablets ZOVIRAX® (acyclovir) Suspension DESCRIPTION ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against ...

custom-source

2025-02-12T13:46:42.812966

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf', 'application_number': 20089, 'submission_type': 'SUPPL ', 'submission_number': 18}

12,201

DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension and as a st...

custom-source

2025-02-12T13:46:42.886910

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 12}

12,203

1 23-4526-00-1 PATIENT INFORMATION DIFLUCAN (fluconazole tablets) This leaflet contains important information about DIFLUCAN (dye-FLEW-kan). It is not meant to take the place of your doctor's instructions. Read this information carefully before you take DIFLUCAN. Ask your doctor or pharmacist if you do no...

custom-source

2025-02-12T13:46:43.031390

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 19}

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1 PATIENT INFORMATION DIFLUCAN (fluconazole tablets) This leaflet contains important information about DIFLUCAN (dye-FLEW-kan). It is not meant to take the place of your doctor's instructions. Read this information carefully before you take DIFLUCAN. Ask your doctor or pharmacist if you do not understand any of this i...

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2025-02-12T13:46:43.125494

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12,198

SPORANOX® (itraconazole) Capsules BOXED WARNING Congestive Heart Failure, Cardiac Effects and Drug Interactions: SPORANOX® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a histo...

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2025-02-12T13:46:43.207193

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DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral admin...

custom-source

2025-02-12T13:46:43.297615

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12,205

DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral admin...

custom-source

2025-02-12T13:46:43.394298

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 31}

12,208

s t ruc tur al f or mu la DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® ...

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2025-02-12T13:46:43.662170

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DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral adminis...

custom-source

2025-02-12T13:46:43.773105

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020090s034lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 34}

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s t ruc tur al f or mu la DIFLUCAN® (Fluconazole Tablets) (Fluconazole Injection - for intravenous infusion only) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as ...

custom-source

2025-02-12T13:46:44.002033

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 38}

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s t ruc tur al f or mu la DIFLUCAN® (Fluconazole Tablets) (Fluconazole for Oral Suspension) DESCRIPTION DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole a...

custom-source

2025-02-12T13:46:44.054583

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf', 'application_number': 20090, 'submission_type': 'SUPPL ', 'submission_number': 44}

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1 1 2 3 4 5 PV 5324 DPP PROZAC® FLUOXETINE CAPSULES, USP FLUOXETINE ORAL SOLUTION, USP FLUOXETINE DELAYED-RELEASE CAPSULES, USP WARNING 6 Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to 7 placebo of suicidal thinking and behavior (suicidality) in children, adolescent...

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2025-02-12T13:46:44.484531

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf', 'application_number': 20101, 'submission_type': 'SUPPL ', 'submission_number': 37}

12,214

1 PV 5326 DPP 1 PROZAC® 2 FLUOXETINE CAPSULES, USP 3 FLUOXETINE ORAL SOLUTION, USP 4 FLUOXETINE DELAYED-RELEASE CAPSULES, USP 5 WARNING 6 Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to 7 placebo of suicidal thinking and behavior (suicidality) in children, adolescen...

custom-source

2025-02-12T13:46:44.486115

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf', 'application_number': 20101, 'submission_type': 'SUPPL ', 'submission_number': 39}

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MIVACRON® Injection (mivacurium chloride) This drug should be administered only by adequately trained individuals familiar with its actions, characteristics, and hazards. DESCRIPTION MIVACRON (mivacurium chloride) is a short-acting, ...

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2025-02-12T13:46:44.673522

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020098s018lbl.pdf', 'application_number': 20098, 'submission_type': 'SUPPL ', 'submission_number': 18}

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1 PV 5321 DPP PROZAC® FLUOXETINE CAPSULES, USP FLUOXETINE ORAL SOLUTION, USP WARNING Suicidality in Children and Adolescents — Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psyc...

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2025-02-12T13:46:45.049731

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf', 'application_number': 20101, 'submission_type': 'SUPPL ', 'submission_number': 35}

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PRESCRIBING INFORMATION ZOFRAN® (ondansetron hydrochloride) Tablets ZOFRAN ODT® (ondansetron) Orally Disintegrating Tablets ZOFRAN® (ondansetron hydrochloride) Oral Solution DESCRIPTION The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate...

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2025-02-12T13:46:45.191547

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 27}

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structural formula PRESCRIBING INFORMATION ZOFRAN® (ondansetron hydrochloride) Tablets ZOFRAN ODT® (ondansetron) Orally Disintegrating Tablets ZOFRAN® (ondansetron hydrochloride) Oral Solution DESCRIPTION The active ingredient in ZOFRAN Tablets and ZOFRAN Oral S...

custom-source

2025-02-12T13:46:45.258508

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 30}

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PRESCRIBING INFORMATION ZOFRAN® (ondansetron hydrochloride) Tablets ZOFRAN ODT® (ondansetron) Orally Disintegrating Tablets ZOFRAN® (ondansetron hydrochloride) Oral Solution DESCRIPTION The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hyd...

custom-source

2025-02-12T13:46:45.263422

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 29}

12,219

1 2 PRESCRIBING INFORMATION 3 ZOFRAN® 4 (ondansetron hydrochloride) 5 Tablets 6 7 ZOFRAN ODT® 8 (ondansetron) 9 Orally Disintegrating Tablets 10 11 ...

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2025-02-12T13:46:45.481258

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf', 'application_number': 20103, 'submission_type': 'SUPPL ', 'submission_number': 34}

12,220

Xttrium Laboratories, Inc. Confidential Page 24 of 24 Chlorhexidine Gluconate 0.75% Solution Section 1.14.1-Draft Labeling Amendment to NDA 20-111/ -Revision Request Attachment # 1: NDA 20-111 -Revised labeling, 4-ounce Dyna-Hex 0.75% CHG Reference ...

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2025-02-12T13:46:45.520327

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020111Orig1s007lbl.pdf', 'application_number': 20111, 'submission_type': 'SUPPL ', 'submission_number': 7}

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1 SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants are: Molecular weight 168.04 ...

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2025-02-12T13:46:45.659128

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s012lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 12}

12,221

NDA 20-118/S-010 Page 3 SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants are: Mole...

custom-source

2025-02-12T13:46:45.694858

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s010lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 10}

12,223

SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants ar...

custom-source

2025-02-12T13:46:45.896006

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020118s016lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 16}

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_______________________________________________________________________________________________________________________________ ...

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2025-02-12T13:46:46.085429

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020118s017lbl.pdf', 'application_number': 20118, 'submission_type': 'SUPPL ', 'submission_number': 17}

12,226

Muro Pharmaceutical, Inc. Tri-Nasal Spray ® NDA #20-120 Amendment Page 1 ))))))))))))))))))))))))))))))))))))))))))) D R A F T TRI-NASAL SPRAY (triamcinolone ® acetonide nasal spray, 50 mcg) For Intranasal Use Only DESCRIPTION: Triamcinolone acetonide, the active ingredient of Tri-Nasal Spray, is a corticosteroid ...

custom-source

2025-02-12T13:46:46.093833

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20120lbl.pdf', 'application_number': 20120, 'submission_type': 'ORIG ', 'submission_number': 1}

12,225

VUMON® (teniposide injection) WARNING VUMON (teniposide injection) is a cytotoxic drug which should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when ...

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2025-02-12T13:46:46.114961

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020119s010s011lbl.pdf', 'application_number': 20119, 'submission_type': 'SUPPL ', 'submission_number': 11}

12,227

DESCRIPTION Triamcinolone acetonide, the active ingredient of AllerNaze, is a corticosteroid with the chemical name, 9α-Fluoro-11β,16α, 17, 21 tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone (C24 H31 FO6 ). Its structural formula is: Structural Formula Triamcinolone acetoni...

custom-source

2025-02-12T13:46:46.331088

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020120s002lbl.pdf', 'application_number': 20120, 'submission_type': 'SUPPL ', 'submission_number': 2}

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2025-02-12T13:46:46.473767

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf', 'application_number': 20121, 'submission_type': 'SUPPL ', 'submission_number': 9}

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...

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2025-02-12T13:46:46.771833

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf', 'application_number': 20121, 'submission_type': 'SUPPL ', 'submission_number': 44}

12,229

PRESCRIBING INFORMATION 1 FLONASE® 2 (fluticasone propionate) 3 Nasal Spray, 50 mcg 4 SHAKE GENTLY 5 For Intranasal Use Only. BEFORE USE. 6 DESCRIPTION 7 Fluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic 8 corticosteroid having the chemical name S-(fluoromethyl...

custom-source

2025-02-12T13:46:46.863569

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf', 'application_number': 20121, 'submission_type': 'SUPPL ', 'submission_number': 30}

12,231

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all of the information needed to use OMNISCAN safely and effectively. See fulI prescribing information for OMNISCAN. OMNISCAN™ (gadodiamide) Injection for Intravenons Use Initial U.S. Approval: 1993 WARNING: NOT FOR INTRATHECAL USE and NEPHROGENIC SY...

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2025-02-12T13:46:46.915367

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf', 'application_number': 20123, 'submission_type': 'SUPPL ', 'submission_number': 35}

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_______________________________________________________________________________________________________________________________________ ...

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2025-02-12T13:46:46.997112

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12,234

ACCURETIC™ (quinapril HCl/hydrochlorothiazide) Tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACCURETIC should be discontinued as soon as possible. See ...

custom-source

2025-02-12T13:46:47.306456

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 7}

12,235

ACCURETIC™ (quinapril HCl/hydrochlorothiazide) Tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACCURETIC should be discontinued as soon as possible. See WARNINGS:...

custom-source

2025-02-12T13:46:47.452661

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 10}

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...

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2025-02-12T13:46:47.532685

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12,236

ACCURETIC (quinapril HCl/hydrochlorothiazide) Tablets WARNING: FETAL TOXICITY  When pregnancy is detected, discontinue ACCURETIC as soon as possible.  Drugs that act ...

custom-source

2025-02-12T13:46:47.689921

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 18}

12,237

ACCURETIC (quinapril HCl/hydrochlorothiazide) Tablets WARNING: FETAL TOXICITY  When pregnancy is detected, discontinue ACCURETIC 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...

custom-source

2025-02-12T13:46:47.806591

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf', 'application_number': 20125, 'submission_type': 'SUPPL ', 'submission_number': 20}

12,239

NDA 21-276 Final Labeling June 29, 2001 1 ESTROSTEP® (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP) ESTROSTEP® 21 (Each white triangular tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each white square tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each wh...

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2025-02-12T13:46:48.089623

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf', 'application_number': 20130, 'submission_type': 'SUPPL ', 'submission_number': 7}

12,238

ZONALON® (doxepin hydrochloride) CREAM, 5% FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. DESCRIPTION Zonalon (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride is one of a...

custom-source

2025-02-12T13:46:48.209490

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf', 'application_number': 20126, 'submission_type': 'SUPPL ', 'submission_number': 6}

12,241

ProHance® (Gadoteridol) Injection, 279.3 mg/mL WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not availabl...

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2025-02-12T13:46:48.233967

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf', 'application_number': 20131, 'submission_type': 'SUPPL ', 'submission_number': 26}

12,240

ProHance(8 Multipack™ (Gadoteridol) Injection, 279.3 mg/mL Pharmacy Bulk Package -...Page 1 of9 Prohance Multipack (gadoteridol) Injection, Solution (Bracco Diagnostics Inc. i Pharmacy Bulk Package - Not for Direct Infusion WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for ne...

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2025-02-12T13:46:48.354969

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf', 'application_number': 20131, 'submission_type': 'SUPPL ', 'submission_number': 23}

12,243

NDA 20136/S-023 Page 3 Demadex (torsemide) Tablets DESCRIPTION Demadex (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1 isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula is: Structural Formula Its em...

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2025-02-12T13:46:48.508284

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020136s023lbl.pdf', 'application_number': 20136, 'submission_type': 'SUPPL ', 'submission_number': 23}

12,244

1 2 DEMADEX 3 (torsemide) 4 TABLETS 5 IN-0455-0X Rev. 08/12 6 DESCRIPTION 7 DEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class. Its chemical 8 name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl] urea and its structural formula 9 is: structural formula 10 11 I...

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2025-02-12T13:46:48.804723

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020136s014lbl.pdf', 'application_number': 20136, 'submission_type': 'SUPPL ', 'submission_number': 24}

12,245

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Levoleucovorin safely and effectively. See full prescribing information for Levoleucovorin. Levoleucovorin (for Injection) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAVENOUS use Initial U.S. Approva...

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2025-02-12T13:46:48.854324

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf', 'application_number': 20140, 'submission_type': 'ORIG ', 'submission_number': 1}

12,242

1 PRESCRIBING INFORMATION 2 IMITREX® 3 (sumatriptan succinate) 4 Tablets 5 DESCRIPTION 6 IMITREX Tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 7 receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2 8 (dimethylamino)e...

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2025-02-12T13:46:48.968210

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf', 'application_number': 20132, 'submission_type': 'SUPPL ', 'submission_number': 20}

12,246

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fusilev safely and ...

custom-source

2025-02-12T13:46:48.977041

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf', 'application_number': 20140, 'submission_type': 'SUPPL ', 'submission_number': 1}

12,247

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information...

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2025-02-12T13:46:49.442616

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf', 'application_number': 20140, 'submission_type': 'SUPPL ', 'submission_number': 2}

12,248

structural formula company logo Cataflam® (diclofenac potassium immediate-release tablets) Tablets of 50 mg Rx only Prescribing Information CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fat...

custom-source

2025-02-12T13:46:49.492101

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf', 'application_number': 20142, 'submission_type': 'SUPPL ', 'submission_number': 21}

12,249

structural formula company logo Cataflam® (diclofenac potassium immediate-release tablets) Tablets of 50 mg Rx only Prescribing Information CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fat...

custom-source

2025-02-12T13:46:49.555025

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf', 'application_number': 20142, 'submission_type': 'SUPPL ', 'submission_number': 22}

12,250

N5-929 S-032 S-033 Package Insert Page 1 T2001-89 89014801 D.H.E. 45® (dihydroergotamine mesylate) Injection, USP Rx only Prescribing Information WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibito...

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2025-02-12T13:46:49.665634

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf', 'application_number': 20148, 'submission_type': 'SUPPL ', 'submission_number': 7}

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Effexor Relapse/Recurrence CONFIDENTIAL 1 16 Mar 01 Effexor  (venlafaxine hydrochloride) Tablets DESCRIPTION Effexor (venlafaxine hydrochloride) is a structurally novel antidepressant for oral administration. It is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. It is designa...

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2025-02-12T13:46:50.509697

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1 Effexor (venlafaxine hydrochloride) Tablets only This product’s label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. DESCRIPTION Effe...

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2025-02-12T13:46:50.872519

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1 Effexor (venlafaxine hydrochloride) Tablets only This product’s label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. DESCRIPTION Effe...

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2025-02-12T13:46:50.931555

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1 Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality in Children and Adolescents Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short- term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering ...

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2025-02-12T13:46:51.285791

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Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) ...

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2025-02-12T13:46:51.369626

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Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and o...

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2025-02-12T13:46:51.918723

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Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) ...

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2025-02-12T13:46:51.978796

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Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and o...

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2025-02-12T13:46:52.086036

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Effexor® (venlafaxine hydrochloride) Tablets Rx only Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychia...

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2025-02-12T13:46:52.170691

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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 of ...

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2025-02-12T13:46:52.243327

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ApprovletS037.doc (clean copy 27March02) Page 4 of 39 Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AN...

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2025-02-12T13:46:52.731851

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Page 4 of 39 Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED ...

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2025-02-12T13:46:53.004644

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January 27, 2003 Page 4 of 70 VDXribaJan03FDA.doc (clean) Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING ...

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2025-02-12T13:46:53.416756

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NDA 20-154/S-044 NDA 20-155/S-034 NDA 20-156/S-035 NDA 21-183/S-010 Page 3 Rx only VIDEX EC (didanosine) VIDEX EC (didanosine) Delayed-Release Capsules Enteric-Coated Beadlets (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH DIDANOSINE...

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NDA 20-154/S-050 NDA 20-155/S-039 NDA 20-156/S-040 NDA 21-183/S-016 Page 5 of 72 Rx only VIDEX® (didanosine) VIDEX® (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN...

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2025-02-12T13:46:53.686294

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Page 4 of 39 Rx only VIDEX (didanosine) VIDEX (didanosine) Chewable/Dispersible Buffered Tablets VIDEX (didanosine) Buffered Powder for Oral Solution VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED ...

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2025-02-12T13:46:53.848227

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