HenriLD/FDA_Docs · Datasets at Hugging Face

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10,883	...	custom-source	2025-02-12T13:43:58.969317	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf', 'application_number': 16320, 'submission_type': 'SUPPL ', 'submission_number': 63}
10,885	NDA 16-324/S-031 NDA 17-391/S-014 Page 3 PRODUCT INFORMATION Imuran® (azathioprine) 50-mg Scored Tablets 100 mg (as the sodium salt) for I.V. injection, Equivalent to 100 mg azathioprine sterile lyophilized mate...	custom-source	2025-02-12T13:43:59.134530	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf', 'application_number': 16324, 'submission_type': 'SUPPL ', 'submission_number': 31}
10,886	PRODUCT INFORMATION ® IMURAN (azathioprine) 50-mg Scored Tablets Rx only WARNING - MALIGNANCY Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy i...	custom-source	2025-02-12T13:43:59.232640	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf', 'application_number': 16324, 'submission_type': 'SUPPL ', 'submission_number': 34}
10,887	5% DEXTROSE Injection, USP Trade Name® Container Rx only DESCRIPTION 5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hy...	custom-source	2025-02-12T13:43:59.253947	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf', 'application_number': 16367, 'submission_type': 'SUPPL ', 'submission_number': 178}
10,888	5% Dextrose Injection, USP 25 mL TO OPEN-TEAR AT NOTCH NDC 0409-7923-20 Four Units (01) 1 030409 792320 2 Each 100 mL contains dextrose, hydrous 5 g. 252 mOsmol/liter (CALC.). pH 4.3 (3.2 to 6.5). Dextrose solutions without salts should not be used in blood transfusions because of possible rouleau formation. Single-d...	custom-source	2025-02-12T13:43:59.289250	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf', 'application_number': 16367, 'submission_type': 'SUPPL ', 'submission_number': 182}
10,891	1 Propranolol Hydrochloride Injection, USP Rx only DESCRIPTION Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)-1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is: s tructural formula Propranolol hydrochloride is a...	custom-source	2025-02-12T13:43:59.603062	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016419s029lbl.pdf', 'application_number': 16419, 'submission_type': 'SUPPL ', 'submission_number': 29}
10,890	Inderal® (propranolol hydrochloride) Tablets Rx 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 1-888-383-1733...	custom-source	2025-02-12T13:43:59.771912	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf', 'application_number': 16418, 'submission_type': 'SUPPL ', 'submission_number': 80}
10,889	Inderal® (propranolol hydrochloride) Tablets Rx 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. DE...	custom-source	2025-02-12T13:43:59.852429	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf', 'application_number': 16418, 'submission_type': 'SUPPL ', 'submission_number': 78}
10,892	NDA 16-466/S-040 NDA 16-466/S-041 Page 3 Aristospan® (Triamcinolone Hexacetonide Injectable Suspension, USP) 5 mg/mL PARENTERAL NOT FOR USE IN NEWBORNS FOR INTRALESIONAL ADMINISTRATION NOT FOR INTRAVENOUS USE DESCRIPTION A sterile suspension containing 5 mg/...	custom-source	2025-02-12T13:43:59.934663	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf', 'application_number': 16466, 'submission_type': 'SUPPL ', 'submission_number': 40}
10,895	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:00.223030	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf', 'application_number': 16584, 'submission_type': 'SUPPL ', 'submission_number': 47}
10,896	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:00.244469	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf', 'application_number': 16584, 'submission_type': 'SUPPL ', 'submission_number': 56}
10,894	...	custom-source	2025-02-12T13:44:00.318479	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf', 'application_number': 16517, 'submission_type': 'SUPPL ', 'submission_number': 13}
10,899	Page 3 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNING SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 A...	custom-source	2025-02-12T13:44:00.575278	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 98}
10,897	NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis— Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an inc...	custom-source	2025-02-12T13:44:00.614584	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf', 'application_number': 16584, 'submission_type': 'SUPPL ', 'submission_number': 58}
10,893	...	custom-source	2025-02-12T13:44:00.940424	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf', 'application_number': 16517, 'submission_type': 'SUPPL ', 'submission_number': 11}
10,898	NDA 016608/S-097 NDA 018281/S-045 NDA 018927/S-038 NDA 020234/S-026 FDA Approved Labeling Text dated 8/28/2015 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red...	custom-source	2025-02-12T13:44:01.088099	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 97}
10,901	company logo Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) 100 mg, 200 mg, 400 mg Rx only Prescribing Information WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND...	custom-source	2025-02-12T13:44:01.282719	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 102}
10,900	NDA 016608/S-099 NDA 018281/S-047 NDA 018927/S-040 NDA 020234/S-030 FDA Approved Labeling Text dated 9/12/2014 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - ...	custom-source	2025-02-12T13:44:01.364160	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 99}
10,902	N 016608/S-103 N 018281/S-051 N 020234/S-035 N 018927/S-044 FDA Approved labeling dated 01/16/2014 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red-speckled, pink Tablets of 200 mg – pink Suspension of 100 mg/5 mL Tegretol®-XR (carbamazepine extended-release tablets) ...	custom-source	2025-02-12T13:44:01.497928	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 103}
10,903	s t r uctur a l f ormu l a ...	custom-source	2025-02-12T13:44:01.572291	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016620s072lbl.pdf', 'application_number': 16620, 'submission_type': 'SUPPL ', 'submission_number': 72}
10,904	NDA 16-624/S-041 Page 3 ALLERGAN HMS (medrysone ophthalmic suspension) 1% Sterile DESCRIPTION HMS (medrysone ophthalmic suspension) 1 % is a topical anti-inflammatory agent for ophthalmic use. Structural Formula: [structure] Medrysone Chemical Name: 11β-hydroxy-6α-methylpregn-4-ene-3,20-dione....	custom-source	2025-02-12T13:44:01.684069	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16624s41lbl.pdf', 'application_number': 16624, 'submission_type': 'SUPPL ', 'submission_number': 41}
10,905	Dextrose Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intra...	custom-source	2025-02-12T13:44:01.764450	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf', 'application_number': 16673, 'submission_type': 'SUPPL ', 'submission_number': 147}
10,907	07-19-69-742 Baxter Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal p...	custom-source	2025-02-12T13:44:01.932741	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 147}
10,909	Sodium Chloride Injection, USP in VIAFLO Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Com...	custom-source	2025-02-12T13:44:02.425736	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 150}
10,908	Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous adm...	custom-source	2025-02-12T13:44:02.513545	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 148}
10,910	07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...	custom-source	2025-02-12T13:44:02.529216	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16678, 'submission_type': 'SUPPL ', 'submission_number': 105}
10,906	NDA 13-684/S-092, 16-677/S-139, 16-678/S-100, 16-679/S-099, 16-682/S-100, 16-683/S-096, 16-687/S-097, 16-689/S-100, 16-692/S-091, 16-693/S-091, 16-695/S-093, 16-696/S-094, 16-697/S-093, 17-378/S-063, 17-385/S-055, 17-390/S-060, 17-438/S-059, 17-451/S-058, 17-484/S-062, 17-634/S-065, 17-648/S-065, 18-008/S-065, 1...	custom-source	2025-02-12T13:44:02.817674	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 139}
10,912	07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...	custom-source	2025-02-12T13:44:02.922973	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16687, 'submission_type': 'SUPPL ', 'submission_number': 102}
10,913	07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...	custom-source	2025-02-12T13:44:02.932181	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16689, 'submission_type': 'SUPPL ', 'submission_number': 105}
10,911	07-19-63-782 Baxter Lactated Ringer’s and 5% Dextrose Injection, USP in VIAFLEX Plastic Container DESCRIPTION Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intr...	custom-source	2025-02-12T13:44:03.193814	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf', 'application_number': 16679, 'submission_type': 'SUPPL ', 'submission_number': 104}
10,916	07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...	custom-source	2025-02-12T13:44:03.275147	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16697, 'submission_type': 'SUPPL ', 'submission_number': 96}
10,914	Ringer’s Injection, USP in VIAFLEX Plastic Container DESCRIPTION Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose contai...	custom-source	2025-02-12T13:44:03.335111	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016693s098lbl.pdf', 'application_number': 16693, 'submission_type': 'SUPPL ', 'submission_number': 98}
10,915	07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...	custom-source	2025-02-12T13:44:03.344707	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16696, 'submission_type': 'SUPPL ', 'submission_number': 97}
10,917	MEDICATION GUIDE Dalmane® (DAL-main) Capsules, 15 mg and 30 mg is a Sedative-Hypnotic indicated for Insomnia Generic name: flurazepam (flew-raz-e-pam) hydrochloride capsules only Read this Medication Guide carefully before you start taking your medicine and each ...	custom-source	2025-02-12T13:44:03.494508	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf', 'application_number': 16721, 'submission_type': 'SUPPL ', 'submission_number': 77}
10,918	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:03.506930	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf', 'application_number': 16758, 'submission_type': 'SUPPL ', 'submission_number': 17}
10,920	NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis— Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an inc...	custom-source	2025-02-12T13:44:03.657306	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf', 'application_number': 16758, 'submission_type': 'SUPPL ', 'submission_number': 20}
10,919	1 NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate DESCRIPTION Navane® (thiothixene) is a thioxanthene derivative. Specifically, it is the cis isomer of N,N- dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene] thioxanthene-2-sulfonamide. SO2N(CH3)2 C H CH2C...	custom-source	2025-02-12T13:44:03.689506	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf', 'application_number': 16758, 'submission_type': 'SUPPL ', 'submission_number': 19}
10,923	Pliva Surmontil Rev. 6/07 Size: 13 x 16.5 Fold: 1-3/8 x 1-3/8 Type: 6 pt. Page 1 6/22/07 JB DESCRIPTION Surmontil (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11- dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form). Molecular Formula: C20H26N2 • C4H4O4 Molecu...	custom-source	2025-02-12T13:44:03.912752	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 25}
10,922	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	2025-02-12T13:44:03.973067	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 24}
10,925	SURMONTIL® (Trimipramine Maleat...	custom-source	2025-02-12T13:44:04.131307	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 37}
10,927	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:04.199866	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf', 'application_number': 16851, 'submission_type': 'SUPPL ', 'submission_number': 51}
10,926	This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda This label may not be the latest approved by FDA. For cu...	custom-source	2025-02-12T13:44:04.250959	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf', 'application_number': 16831, 'submission_type': 'SUPPL ', 'submission_number': 49}
10,924	SURMONTIL® (Trimipramine Maleate) Rx only Rev. November 2012 XXXXX Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in chi...	custom-source	2025-02-12T13:44:04.314818	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 34}
10,928	NDA 16-851/S-063 Page 3 FML® (fluorometholone ophthalmic suspension, USP) 0.1% sterile DESCRIPTION FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Chemical Name Fluorometholone: 9-Fluoro-11ß,17-di...	custom-source	2025-02-12T13:44:04.338308	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf', 'application_number': 16851, 'submission_type': 'SUPPL ', 'submission_number': 63}
10,929	CIV DARVON-N® (PROPOXYPHENE NAPSYLATE TABLETS, USP) TABLETS Rx only WARNINGS • There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hou...	custom-source	2025-02-12T13:44:04.425930	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf', 'application_number': 16862, 'submission_type': 'SUPPL ', 'submission_number': 42}
10,933	1 NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate DESCRIPTION Navane® (thiothixene) is a thioxanthene derivative. Specifically, it is the cis isomer of N,N- dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene] thioxanthene-2-sulfonamide. SO2N(CH3)2 C H CH2C...	custom-source	2025-02-12T13:44:04.586421	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf', 'application_number': 16904, 'submission_type': 'SUPPL ', 'submission_number': 33}
10,930	Rx only NDA 16-885/S-023 Page 3 LYSODREN® (mitotane tablets, USP) WARNINGS LYSODREN (mitotane tablets, USP) should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. LYSODREN should be temporarily discontinued immedi...	custom-source	2025-02-12T13:44:04.644816	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 23}
10,932	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information neede...	custom-source	2025-02-12T13:44:04.716195	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 26}
10,934	NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis— Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an inc...	custom-source	2025-02-12T13:44:04.777180	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf', 'application_number': 16904, 'submission_type': 'SUPPL ', 'submission_number': 34}
10,931	LYSODREN® (mitotane tablets, USP) WARNINGS LYSODREN (mitotane tablets, USP) should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. LYSODREN should be temporarily discontinued immediately following shock or severe trauma since adrenal ...	custom-source	2025-02-12T13:44:04.865924	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 25}
10,935	RETIN-A® Cream Gel Liquid (tretinoin) For Topical Use Only Prescribing Information Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ...	custom-source	2025-02-12T13:44:04.993577	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 16921, 'submission_type': 'SUPPL ', 'submission_number': 22}
10,937	NDA 16-931/S-028 Page 3 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda NDA 16-931/S-028 Page 4 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/dr...	custom-source	2025-02-12T13:44:05.062030	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-gene_lbl.pdf', 'application_number': 16931, 'submission_type': 'SUPPL ', 'submission_number': 28}
10,936	RETIN-A® Cream Gel Liquid (tretinoin) For Topical Use Only Prescribing Information Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ...	custom-source	2025-02-12T13:44:05.063623	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 16921, 'submission_type': 'SUPPL ', 'submission_number': 25}
10,938	R-Gene® 10 Arginine Hydrochloride Injection, USP For Intravenous Use DESCRIPTION Each 100 mL of R-Gene® 10 (Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP (equivalent to a 10% solut...	custom-source	2025-02-12T13:44:05.188154	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf', 'application_number': 16931, 'submission_type': 'SUPPL ', 'submission_number': 31}
10,940	ORTHO MICRONOR® Tablets (norethindrone) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION ORTHO MICRONOR® Tablets Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn s...	custom-source	2025-02-12T13:44:05.549851	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf', 'application_number': 16954, 'submission_type': 'SUPPL ', 'submission_number': 101}
10,939	...	custom-source	2025-02-12T13:44:05.814856	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf', 'application_number': 16949, 'submission_type': 'SUPPL ', 'submission_number': 39}
10,942	PMS Black Last Time Saved: 11/24/2009 3:16 PM Document Name: QEN-2316v1.qxp EN-2316 The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and due ...	custom-source	2025-02-12T13:44:05.818025	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016964s069lbl.pdf', 'application_number': 16964, 'submission_type': 'SUPPL ', 'submission_number': 69}
10,941	Drawing #: DD301300 Style: N9 Dimensions: 7-5/8” x 3” x 2-13/16” x 2-31/32” x 3-1/4” CA-XXXX (XX/XX) 0 9 8 7 6 5 4 3 2 1 2. 1/16 INCH QUIET ZONE REQUIRED ON ALL SIDES OF COMMODITY NUMBER. COMMODITY NUMBERS TO BE 8 POINT FUTURA REGULAR. 3. UNVARNISHED AND COPY FREE LOCATION FOR PRINTING LOT, EXP. AND MFG. DATE, ET...	custom-source	2025-02-12T13:44:05.819427	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016964s061lbl.pdf', 'application_number': 16964, 'submission_type': 'SUPPL ', 'submission_number': 61}
10,946	...	custom-source	2025-02-12T13:44:06.208193	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf', 'application_number': 16988, 'submission_type': 'SUPPL ', 'submission_number': 30}
10,943	MarcaineTM Bupivacaine Hydrochloride Injection, USP MarcaineTM With Epinephrine 1:200,000 (as bitartrate) Bupivacaine Hydrochloride and Epinephrine Injection, USP Rx only DESCRIPTION Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohyd...	custom-source	2025-02-12T13:44:06.209804	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016964s070lbl.pdf', 'application_number': 16964, 'submission_type': 'SUPPL ', 'submission_number': 70}
10,945	...	custom-source	2025-02-12T13:44:06.213697	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf', 'application_number': 16968, 'submission_type': 'SUPPL ', 'submission_number': 29}
10,944	NDA 16-968/S-020 Page 3 M IOSTAT® (CARBACHOLINTRAOCULAR SOLUTION, USP) 0.01% DESCRIPTION: MIOSTAT® (carbachol intraocular solution, USP) is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure: Established name: ...	custom-source	2025-02-12T13:44:06.360809	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf', 'application_number': 16968, 'submission_type': 'SUPPL ', 'submission_number': 20}
10,947	ANCOBON® (flucytosine) CAPSULES DESCRIPTION Ancobon (flucytosine), an antifungal agent, is available as 250mg and 500mg capsules for oral administration. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells contain parabens (butyl, methyl, propyl) and sodium propionate, with the ...	custom-source	2025-02-12T13:44:06.478962	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf', 'application_number': 17001, 'submission_type': 'SUPPL ', 'submission_number': 27}
10,948	PAVULON® (pancuronium bromide) injection NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS. DESCRIPTION: PAVULON® (pancuronium bromide) injection is a nondepolarizing neurom...	custom-source	2025-02-12T13:44:06.519893	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf', 'application_number': 17015, 'submission_type': 'SUPPL ', 'submission_number': 23}
10,949	c o mp an y logo 4 HEPARIN SODIUM 5 INJECTION, USP 6 Rx only 7 8 DERIVED FROM PORCINE INTESTINAL MUCOSA. 9 Available as: Preservative Free or Contains Benzyl Alcohol or Parabens 10 DESCRIPTION: 11 Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called 12 glyc...	custom-source	2025-02-12T13:44:06.637461	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf', 'application_number': 17029, 'submission_type': 'SUPPL ', 'submission_number': 120}
10,950	NDA 17-037/S-154/S-1565/S-156 Page 3 HEP-LOCK U/P Preservative-Free (Heparin Lock Flush Solution, USP) Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars...	custom-source	2025-02-12T13:44:06.681244	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 154}
10,952	Package Label Image 462-520-01 Label, Heparin Sodium Injection, USP, 5,000 units/mL, 10 mL Multiple Dose Vial Size: 1 1/8” x 2 7/8” USA Submission - 1 Corner: 1/8” 5/21/2009 PMS 151 PMS 1555 PMS 185 Black Bar Code: GS1 Data Bar (Limited 25/3) Multi-Color Pharmacode (67): Pr...	custom-source	2025-02-12T13:44:06.891511	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 165}
10,953	Heparin Sodium Injection, USP Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, ...	custom-source	2025-02-12T13:44:07.045437	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 168}
10,954	Heparin Sodium Injection, USP Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) -L-iduronic acid 2-sulfate, (2) ...	custom-source	2025-02-12T13:44:07.158115	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 169}
10,951	NDA 17-037/S-158 Page 3 Heparin Sodium Injection, USP Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2...	custom-source	2025-02-12T13:44:07.196104	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 158}
10,955	CEBERT PHARMACEUTICALS, INC. DISKETS® Dispersible Tablets CII (Methadone Hydrochloride Tablets, USP), 40 mg Rx only FOR ORAL USE ONLY (Following Dispersion in a Liquid) Deaths have been reported during initiation of methadone treatment for opioid dependence. In some cases, drug interactions with other drugs...	custom-source	2025-02-12T13:44:07.486701	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf', 'application_number': 17058, 'submission_type': 'SUPPL ', 'submission_number': 17}
10,956	...	custom-source	2025-02-12T13:44:07.666734	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf', 'application_number': 17058, 'submission_type': 'SUPPL ', 'submission_number': 21}
10,957	1 DX:L57 PRESCRIBING INFORMATION DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained-release capsules and Tablets WARNING AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION...	custom-source	2025-02-12T13:44:07.704350	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 40}
10,958	DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained release capsules Cll Rx Only WARNING: AMPHETAMINES HAVE A HIGH POTENTIAL FOR...	custom-source	2025-02-12T13:44:07.707761	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 46}
10,960	DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained release capsules Cll Rx Only WARNING: AMPHETAMINES HAVE A HIGH POTENTIAL FOR...	custom-source	2025-02-12T13:44:07.974202	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 48}
10,961	NDA 17-084/S-017 Page 3 Product info This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda NDA 17-084/S-017 Page 4 Phosphocol® P 32 Chromic Phosphate P 32 S...	custom-source	2025-02-12T13:44:08.000542	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017084s017lbl.pdf', 'application_number': 17084, 'submission_type': 'SUPPL ', 'submission_number': 17}
10,959	structural formula DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained release capsules Cll Rx Only WARNING: AMPHETAMINES HAVE A H...	custom-source	2025-02-12T13:44:08.175886	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 47}
10,962	NDA 17-087/S-047 Page 3 ĒTHRANE (enflurane, USP) Liquid For Inhalation Rx only DESCRIPTION ĒTHRANE (enflurane, USP), a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is 2-chloro-1,1,2-trifluoroethyl difluoromethyl ether (CHF2OCF2CHFCl). The boiling point is 56.5º...	custom-source	2025-02-12T13:44:08.178467	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf', 'application_number': 17087, 'submission_type': 'SUPPL ', 'submission_number': 47}
10,963	Ethrane® (enflurane, USP) Page 1 of 9 ĒTHRANE (enflurane, USP) Liquid For Inhalation Rx only DESCRIPTION ĒTHRANE (enflurane, USP), a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is 2-chloro-1,1,2-trifluoroethyl difluoromethyl ether (CHF2OCF2C...	custom-source	2025-02-12T13:44:08.245944	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf', 'application_number': 17087, 'submission_type': 'SUPPL ', 'submission_number': 48}
10,964	Page 1 of 15 Tofranil-PM® imipramine pamoate capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, ado...	custom-source	2025-02-12T13:44:08.342645	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 74}
10,966	Tofranil-PM™ (imipramine pamoate) capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidali...	custom-source	2025-02-12T13:44:08.631289	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 77}
10,967	Tofranil-PM™ (imipramine pamoate) capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking ...	custom-source	2025-02-12T13:44:08.665772	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 78}
10,965	s t r uctural formula Tofranil-PM™ (imipramine pamoate) capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and be...	custom-source	2025-02-12T13:44:08.730786	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 76}
10,968	TRANXENE* T-TAB® Tablets clorazepate dipotassium tablets, USP Rx only DESCRIPTION Chemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4-Benzodiazepine-3-carboxyl...	custom-source	2025-02-12T13:44:08.885460	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf', 'application_number': 17105, 'submission_type': 'SUPPL ', 'submission_number': 75}
10,970	company logo ® MOBAN (Molindone Hydrochloride Tablets, USP) Rx only WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen ...	custom-source	2025-02-12T13:44:08.991893	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf', 'application_number': 17111, 'submission_type': 'SUPPL ', 'submission_number': 67}
10,971	NDA 17-116/S-015 NDA 17-116/S-016 Page 3 CII Methadose® Oral Concentrate (methadone hydrochloride oral concentrate USP) and Methadose® Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored Rx only FOR ORAL USE ONLY CONDITIONS FOR DISTRIBUTION A...	custom-source	2025-02-12T13:44:09.260503	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf', 'application_number': 17116, 'submission_type': 'SUPPL ', 'submission_number': 15}
10,969	Tranxene* T-TAB® Tablets (clorazepate dipotassium tablets, USP) Rx only DESCRIPTION Chemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4-Benzodiazepine-3-carbo...	custom-source	2025-02-12T13:44:09.337020	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf', 'application_number': 17105, 'submission_type': 'SUPPL ', 'submission_number': 76}
10,973	Page 1 Ultra-TechneKow® DTE (Technetium Tc 99m Generator) Rx Only For the Production of Sodium Pertechnetate To 99m Injection DESCRIPTION: The Ultra-TechneKow® DTE Generator is prepared with fission-produced molybdenum Mo 99 adsorbed onto alumina in a lead shielded column. This generator provides a closed sys...	custom-source	2025-02-12T13:44:09.388206	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf', 'application_number': 17243, 'submission_type': 'SUPPL ', 'submission_number': 25}
10,972	CIV DARVOCET-N® 50 and DARVOCET-N® 100 (PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP) Rx only WARNINGS • There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcoho...	custom-source	2025-02-12T13:44:09.419422	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf', 'application_number': 17122, 'submission_type': 'SUPPL ', 'submission_number': 62}
10,975	RETIN-A® Cream Gel Liquid (tretinoin) For Topical Use Only Prescribing Information Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ...	custom-source	2025-02-12T13:44:09.566774	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 17340, 'submission_type': 'SUPPL ', 'submission_number': 32}
10,974	515083-0811 August 2011 XENON Xe 133 GAS FOR DIAGNOSTIC USE DESCRIPTION: Xenon Xe 133 Gas is supplied in a mixture of xenon gas (5%) in carbon dioxide (95%). It is contained within septum sealed glass vials and is suitable for inhalation...	custom-source	2025-02-12T13:44:09.627681	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017284s012lbl.pdf', 'application_number': 17284, 'submission_type': 'SUPPL ', 'submission_number': 12}
10,977	Rx only BACTRIM™ sulfamethoxazole and trimethoprim DS (double strength) tablets and tablets USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethox...	custom-source	2025-02-12T13:44:09.698730	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf', 'application_number': 17377, 'submission_type': 'SUPPL ', 'submission_number': 68}
10,976	only BACTRIM™ brand of sulfamethoxazole and trimethoprim DS (double strength) TABLETS and TABLETS, USP DESCRIPTION BACTRIM (sulfamethoxazole and trimethoprim) is a syn- thetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sul- famethoxazole and 160 mg trimethopr...	custom-source	2025-02-12T13:44:09.815552	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf', 'application_number': 17377, 'submission_type': 'SUPPL ', 'submission_number': 58}
10,978	Rx only BACTRIM™ sulfamethoxazole and trimethoprim DS (double strength) tablets and tablets USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethox...	custom-source	2025-02-12T13:44:09.899489	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf', 'application_number': 17377, 'submission_type': 'SUPPL ', 'submission_number': 73}
10,981	NDA 16-324/S-031 NDA 17-391/S-014 Page 3 PRODUCT INFORMATION Imuran® (azathioprine) 50-mg Scored Tablets 100 mg (as the sodium salt) for I.V. injection, Equivalent to 100 mg azathioprine sterile lyophilized mate...	custom-source	2025-02-12T13:44:10.042383	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf', 'application_number': 17391, 'submission_type': 'SUPPL ', 'submission_number': 14}
10,979	07-19-51-797 Baxter PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in AVIVA Plastic Container DESCRIPTION PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration...	custom-source	2025-02-12T13:44:10.253471	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf', 'application_number': 17378, 'submission_type': 'SUPPL ', 'submission_number': 65}
10,983	Catapres® (clonidine hydrochloride, USP) Boehringer Ingelheim Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information DESCRIPTION Catapres® (clonidine hydrochloride, USP) is a centrally acting alpha-agonist hypotensive agent available as tablets for oral admi...	custom-source	2025-02-12T13:44:10.325632	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf', 'application_number': 17407, 'submission_type': 'SUPPL ', 'submission_number': 34}
10,980	NDA 16-324/S-030 NDA 17-391/S-013 Page 3 PRODUCT INFORMATION IMURAN® (azathioprine) 518700 50-mg Scored Tablets ...	custom-source	2025-02-12T13:44:10.327202	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf', 'application_number': 17391, 'submission_type': 'SUPPL ', 'submission_number': 13}
10,982	NDA 17-398/S-015 Page 3 PACKAGE INSERT REGONOL® (pyridostigmine bromide injection USP) CONTAINS BENZYL ALCOHOL THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS. DESCRIPTION REGONOL® (pyridostigmine bromide injection USP) is an ac...	custom-source	2025-02-12T13:44:10.340572	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf', 'application_number': 17398, 'submission_type': 'SUPPL ', 'submission_number': 15}
10,985	s t ru ct ura l f or mu la Catapres® (clonidine hydrochloride, USP) company logo Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information DESCRIPTION Catapres® (clonidine hydrochloride, USP) is a centrally acting alpha-agonist hypotensive agent available as tablets ...	custom-source	2025-02-12T13:44:10.639673	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf', 'application_number': 17407, 'submission_type': 'SUPPL ', 'submission_number': 37}

10,883

...

custom-source

2025-02-12T13:43:58.969317

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf', 'application_number': 16320, 'submission_type': 'SUPPL ', 'submission_number': 63}

10,885

NDA 16-324/S-031 NDA 17-391/S-014 Page 3 PRODUCT INFORMATION Imuran® (azathioprine) 50-mg Scored Tablets 100 mg (as the sodium salt) for I.V. injection, Equivalent to 100 mg azathioprine sterile lyophilized mate...

custom-source

2025-02-12T13:43:59.134530

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf', 'application_number': 16324, 'submission_type': 'SUPPL ', 'submission_number': 31}

10,886

PRODUCT INFORMATION ® IMURAN (azathioprine) 50-mg Scored Tablets Rx only WARNING - MALIGNANCY Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy i...

custom-source

2025-02-12T13:43:59.232640

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035lbl.pdf', 'application_number': 16324, 'submission_type': 'SUPPL ', 'submission_number': 34}

10,887

5% DEXTROSE Injection, USP Trade Name® Container Rx only DESCRIPTION 5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hy...

custom-source

2025-02-12T13:43:59.253947

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016367s178lbl.pdf', 'application_number': 16367, 'submission_type': 'SUPPL ', 'submission_number': 178}

10,888

5% Dextrose Injection, USP 25 mL TO OPEN-TEAR AT NOTCH NDC 0409-7923-20 Four Units (01) 1 030409 792320 2 Each 100 mL contains dextrose, hydrous 5 g. 252 mOsmol/liter (CALC.). pH 4.3 (3.2 to 6.5). Dextrose solutions without salts should not be used in blood transfusions because of possible rouleau formation. Single-d...

custom-source

2025-02-12T13:43:59.289250

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016367s182lbl.pdf', 'application_number': 16367, 'submission_type': 'SUPPL ', 'submission_number': 182}

10,891

1 Propranolol Hydrochloride Injection, USP Rx only DESCRIPTION Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)-1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is: s tructural formula Propranolol hydrochloride is a...

custom-source

2025-02-12T13:43:59.603062

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016419s029lbl.pdf', 'application_number': 16419, 'submission_type': 'SUPPL ', 'submission_number': 29}

10,890

Inderal® (propranolol hydrochloride) Tablets Rx 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 1-888-383-1733...

custom-source

2025-02-12T13:43:59.771912

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf', 'application_number': 16418, 'submission_type': 'SUPPL ', 'submission_number': 80}

10,889

Inderal® (propranolol hydrochloride) Tablets Rx 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. DE...

custom-source

2025-02-12T13:43:59.852429

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016418s078lbl.pdf', 'application_number': 16418, 'submission_type': 'SUPPL ', 'submission_number': 78}

10,892

NDA 16-466/S-040 NDA 16-466/S-041 Page 3 Aristospan® (Triamcinolone Hexacetonide Injectable Suspension, USP) 5 mg/mL PARENTERAL NOT FOR USE IN NEWBORNS FOR INTRALESIONAL ADMINISTRATION NOT FOR INTRAVENOUS USE DESCRIPTION A sterile suspension containing 5 mg/...

custom-source

2025-02-12T13:43:59.934663

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf', 'application_number': 16466, 'submission_type': 'SUPPL ', 'submission_number': 40}

10,895

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

custom-source

2025-02-12T13:44:00.223030

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf', 'application_number': 16584, 'submission_type': 'SUPPL ', 'submission_number': 47}

10,896

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

custom-source

2025-02-12T13:44:00.244469

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf', 'application_number': 16584, 'submission_type': 'SUPPL ', 'submission_number': 56}

10,894

...

custom-source

2025-02-12T13:44:00.318479

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf', 'application_number': 16517, 'submission_type': 'SUPPL ', 'submission_number': 13}

10,899

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

custom-source

2025-02-12T13:44:00.575278

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 98}

10,897

NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis— Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an inc...

custom-source

2025-02-12T13:44:00.614584

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf', 'application_number': 16584, 'submission_type': 'SUPPL ', 'submission_number': 58}

10,893

...

custom-source

2025-02-12T13:44:00.940424

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf', 'application_number': 16517, 'submission_type': 'SUPPL ', 'submission_number': 11}

10,898

NDA 016608/S-097 NDA 018281/S-045 NDA 018927/S-038 NDA 020234/S-026 FDA Approved Labeling Text dated 8/28/2015 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - red...

custom-source

2025-02-12T13:44:01.088099

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 97}

10,901

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

custom-source

2025-02-12T13:44:01.282719

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 102}

10,900

NDA 016608/S-099 NDA 018281/S-047 NDA 018927/S-040 NDA 020234/S-030 FDA Approved Labeling Text dated 9/12/2014 Page 1 Tegretol® carbamazepine USP Chewable Tablets of 100 mg - ...

custom-source

2025-02-12T13:44:01.364160

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 99}

10,902

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

custom-source

2025-02-12T13:44:01.497928

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf', 'application_number': 16608, 'submission_type': 'SUPPL ', 'submission_number': 103}

10,903

s t r uctur a l f ormu l a ...

custom-source

2025-02-12T13:44:01.572291

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016620s072lbl.pdf', 'application_number': 16620, 'submission_type': 'SUPPL ', 'submission_number': 72}

10,904

NDA 16-624/S-041 Page 3 ALLERGAN HMS (medrysone ophthalmic suspension) 1% Sterile DESCRIPTION HMS (medrysone ophthalmic suspension) 1 % is a topical anti-inflammatory agent for ophthalmic use. Structural Formula: [structure] Medrysone Chemical Name: 11β-hydroxy-6α-methylpregn-4-ene-3,20-dione....

custom-source

2025-02-12T13:44:01.684069

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16624s41lbl.pdf', 'application_number': 16624, 'submission_type': 'SUPPL ', 'submission_number': 41}

10,905

Dextrose Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intra...

custom-source

2025-02-12T13:44:01.764450

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf', 'application_number': 16673, 'submission_type': 'SUPPL ', 'submission_number': 147}

10,907

07-19-69-742 Baxter Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal p...

custom-source

2025-02-12T13:44:01.932741

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 147}

10,909

Sodium Chloride Injection, USP in VIAFLO Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Com...

custom-source

2025-02-12T13:44:02.425736

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 150}

10,908

Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous adm...

custom-source

2025-02-12T13:44:02.513545

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 148}

10,910

07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...

custom-source

2025-02-12T13:44:02.529216

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16678, 'submission_type': 'SUPPL ', 'submission_number': 105}

10,906

NDA 13-684/S-092, 16-677/S-139, 16-678/S-100, 16-679/S-099, 16-682/S-100, 16-683/S-096, 16-687/S-097, 16-689/S-100, 16-692/S-091, 16-693/S-091, 16-695/S-093, 16-696/S-094, 16-697/S-093, 17-378/S-063, 17-385/S-055, 17-390/S-060, 17-438/S-059, 17-451/S-058, 17-484/S-062, 17-634/S-065, 17-648/S-065, 18-008/S-065, 1...

custom-source

2025-02-12T13:44:02.817674

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 16677, 'submission_type': 'SUPPL ', 'submission_number': 139}

10,912

07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...

custom-source

2025-02-12T13:44:02.922973

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16687, 'submission_type': 'SUPPL ', 'submission_number': 102}

10,913

07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...

custom-source

2025-02-12T13:44:02.932181

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16689, 'submission_type': 'SUPPL ', 'submission_number': 105}

10,911

07-19-63-782 Baxter Lactated Ringer’s and 5% Dextrose Injection, USP in VIAFLEX Plastic Container DESCRIPTION Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intr...

custom-source

2025-02-12T13:44:03.193814

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf', 'application_number': 16679, 'submission_type': 'SUPPL ', 'submission_number': 104}

10,916

07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...

custom-source

2025-02-12T13:44:03.275147

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16697, 'submission_type': 'SUPPL ', 'submission_number': 96}

10,914

Ringer’s Injection, USP in VIAFLEX Plastic Container DESCRIPTION Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose contai...

custom-source

2025-02-12T13:44:03.335111

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016693s098lbl.pdf', 'application_number': 16693, 'submission_type': 'SUPPL ', 'submission_number': 98}

10,915

07-19-70-016 Baxter Dextrose and Sodium Chloride Injection, USP in AVIVA Plastic Container DESCRIPTION Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for ...

custom-source

2025-02-12T13:44:03.344707

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf', 'application_number': 16696, 'submission_type': 'SUPPL ', 'submission_number': 97}

10,917

MEDICATION GUIDE Dalmane® (DAL-main) Capsules, 15 mg and 30 mg is a Sedative-Hypnotic indicated for Insomnia Generic name: flurazepam (flew-raz-e-pam) hydrochloride capsules only Read this Medication Guide carefully before you start taking your medicine and each ...

custom-source

2025-02-12T13:44:03.494508

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf', 'application_number': 16721, 'submission_type': 'SUPPL ', 'submission_number': 77}

10,918

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

custom-source

2025-02-12T13:44:03.506930

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf', 'application_number': 16758, 'submission_type': 'SUPPL ', 'submission_number': 17}

10,920

NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis— Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an inc...

custom-source

2025-02-12T13:44:03.657306

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf', 'application_number': 16758, 'submission_type': 'SUPPL ', 'submission_number': 20}

10,919

1 NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate DESCRIPTION Navane® (thiothixene) is a thioxanthene derivative. Specifically, it is the cis isomer of N,N- dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene] thioxanthene-2-sulfonamide. SO2N(CH3)2 C H CH2C...

custom-source

2025-02-12T13:44:03.689506

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf', 'application_number': 16758, 'submission_type': 'SUPPL ', 'submission_number': 19}

10,923

Pliva Surmontil Rev. 6/07 Size: 13 x 16.5 Fold: 1-3/8 x 1-3/8 Type: 6 pt. Page 1 6/22/07 JB DESCRIPTION Surmontil (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11- dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form). Molecular Formula: C20H26N2 • C4H4O4 Molecu...

custom-source

2025-02-12T13:44:03.912752

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 25}

10,922

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

2025-02-12T13:44:03.973067

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 24}

10,925

SURMONTIL® (Trimipramine Maleat...

custom-source

2025-02-12T13:44:04.131307

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 37}

10,927

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

custom-source

2025-02-12T13:44:04.199866

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf', 'application_number': 16851, 'submission_type': 'SUPPL ', 'submission_number': 51}

10,926

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

custom-source

2025-02-12T13:44:04.250959

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf', 'application_number': 16831, 'submission_type': 'SUPPL ', 'submission_number': 49}

10,924

SURMONTIL® (Trimipramine Maleate) Rx only Rev. November 2012 XXXXX Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in chi...

custom-source

2025-02-12T13:44:04.314818

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf', 'application_number': 16792, 'submission_type': 'SUPPL ', 'submission_number': 34}

10,928

NDA 16-851/S-063 Page 3 FML® (fluorometholone ophthalmic suspension, USP) 0.1% sterile DESCRIPTION FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Chemical Name Fluorometholone: 9-Fluoro-11ß,17-di...

custom-source

2025-02-12T13:44:04.338308

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf', 'application_number': 16851, 'submission_type': 'SUPPL ', 'submission_number': 63}

10,929

CIV DARVON-N® (PROPOXYPHENE NAPSYLATE TABLETS, USP) TABLETS Rx only WARNINGS • There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hou...

custom-source

2025-02-12T13:44:04.425930

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf', 'application_number': 16862, 'submission_type': 'SUPPL ', 'submission_number': 42}

10,933

1 NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate DESCRIPTION Navane® (thiothixene) is a thioxanthene derivative. Specifically, it is the cis isomer of N,N- dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene] thioxanthene-2-sulfonamide. SO2N(CH3)2 C H CH2C...

custom-source

2025-02-12T13:44:04.586421

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf', 'application_number': 16904, 'submission_type': 'SUPPL ', 'submission_number': 33}

10,930

Rx only NDA 16-885/S-023 Page 3 LYSODREN® (mitotane tablets, USP) WARNINGS LYSODREN (mitotane tablets, USP) should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. LYSODREN should be temporarily discontinued immedi...

custom-source

2025-02-12T13:44:04.644816

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 23}

10,932

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

custom-source

2025-02-12T13:44:04.716195

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 26}

10,934

NAVANE® Thiothixene Capsules Thiothixene Hydrochloride Concentrate WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis— Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an inc...

custom-source

2025-02-12T13:44:04.777180

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf', 'application_number': 16904, 'submission_type': 'SUPPL ', 'submission_number': 34}

10,931

LYSODREN® (mitotane tablets, USP) WARNINGS LYSODREN (mitotane tablets, USP) should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents. LYSODREN should be temporarily discontinued immediately following shock or severe trauma since adrenal ...

custom-source

2025-02-12T13:44:04.865924

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 25}

10,935

RETIN-A® Cream Gel Liquid (tretinoin) For Topical Use Only Prescribing Information Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ...

custom-source

2025-02-12T13:44:04.993577

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 16921, 'submission_type': 'SUPPL ', 'submission_number': 22}

10,937

NDA 16-931/S-028 Page 3 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda NDA 16-931/S-028 Page 4 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/dr...

custom-source

2025-02-12T13:44:05.062030

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16931slr028_r-gene_lbl.pdf', 'application_number': 16931, 'submission_type': 'SUPPL ', 'submission_number': 28}

10,936

RETIN-A® Cream Gel Liquid (tretinoin) For Topical Use Only Prescribing Information Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ...

custom-source

2025-02-12T13:44:05.063623

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 16921, 'submission_type': 'SUPPL ', 'submission_number': 25}

10,938

R-Gene® 10 Arginine Hydrochloride Injection, USP For Intravenous Use DESCRIPTION Each 100 mL of R-Gene® 10 (Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP (equivalent to a 10% solut...

custom-source

2025-02-12T13:44:05.188154

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016931s031lbl.pdf', 'application_number': 16931, 'submission_type': 'SUPPL ', 'submission_number': 31}

10,940

ORTHO MICRONOR® Tablets (norethindrone) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION ORTHO MICRONOR® Tablets Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn s...

custom-source

2025-02-12T13:44:05.549851

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf', 'application_number': 16954, 'submission_type': 'SUPPL ', 'submission_number': 101}

10,939

...

custom-source

2025-02-12T13:44:05.814856

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf', 'application_number': 16949, 'submission_type': 'SUPPL ', 'submission_number': 39}

10,942

PMS Black Last Time Saved: 11/24/2009 3:16 PM Document Name: QEN-2316v1.qxp EN-2316 The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and due ...

custom-source

2025-02-12T13:44:05.818025

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016964s069lbl.pdf', 'application_number': 16964, 'submission_type': 'SUPPL ', 'submission_number': 69}

10,941

Drawing #: DD301300 Style: N9 Dimensions: 7-5/8” x 3” x 2-13/16” x 2-31/32” x 3-1/4” CA-XXXX (XX/XX) 0 9 8 7 6 5 4 3 2 1 2. 1/16 INCH QUIET ZONE REQUIRED ON ALL SIDES OF COMMODITY NUMBER. COMMODITY NUMBERS TO BE 8 POINT FUTURA REGULAR. 3. UNVARNISHED AND COPY FREE LOCATION FOR PRINTING LOT, EXP. AND MFG. DATE, ET...

custom-source

2025-02-12T13:44:05.819427

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016964s061lbl.pdf', 'application_number': 16964, 'submission_type': 'SUPPL ', 'submission_number': 61}

10,946

...

custom-source

2025-02-12T13:44:06.208193

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf', 'application_number': 16988, 'submission_type': 'SUPPL ', 'submission_number': 30}

10,943

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

custom-source

2025-02-12T13:44:06.209804

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016964s070lbl.pdf', 'application_number': 16964, 'submission_type': 'SUPPL ', 'submission_number': 70}

10,945

...

custom-source

2025-02-12T13:44:06.213697

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf', 'application_number': 16968, 'submission_type': 'SUPPL ', 'submission_number': 29}

10,944

NDA 16-968/S-020 Page 3 M IOSTAT® (CARBACHOLINTRAOCULAR SOLUTION, USP) 0.01% DESCRIPTION: MIOSTAT® (carbachol intraocular solution, USP) is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure: Established name: ...

custom-source

2025-02-12T13:44:06.360809

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf', 'application_number': 16968, 'submission_type': 'SUPPL ', 'submission_number': 20}

10,947

ANCOBON® (flucytosine) CAPSULES DESCRIPTION Ancobon (flucytosine), an antifungal agent, is available as 250mg and 500mg capsules for oral administration. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells contain parabens (butyl, methyl, propyl) and sodium propionate, with the ...

custom-source

2025-02-12T13:44:06.478962

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf', 'application_number': 17001, 'submission_type': 'SUPPL ', 'submission_number': 27}

10,948

PAVULON® (pancuronium bromide) injection NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS. DESCRIPTION: PAVULON® (pancuronium bromide) injection is a nondepolarizing neurom...

custom-source

2025-02-12T13:44:06.519893

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf', 'application_number': 17015, 'submission_type': 'SUPPL ', 'submission_number': 23}

10,949

c o mp an y logo 4 HEPARIN SODIUM 5 INJECTION, USP 6 Rx only 7 8 DERIVED FROM PORCINE INTESTINAL MUCOSA. 9 Available as: Preservative Free or Contains Benzyl Alcohol or Parabens 10 DESCRIPTION: 11 Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called 12 glyc...

custom-source

2025-02-12T13:44:06.637461

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf', 'application_number': 17029, 'submission_type': 'SUPPL ', 'submission_number': 120}

10,950

NDA 17-037/S-154/S-1565/S-156 Page 3 HEP-LOCK U/P Preservative-Free (Heparin Lock Flush Solution, USP) Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars...

custom-source

2025-02-12T13:44:06.681244

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 154}

10,952

Package Label Image 462-520-01 Label, Heparin Sodium Injection, USP, 5,000 units/mL, 10 mL Multiple Dose Vial Size: 1 1/8” x 2 7/8” USA Submission - 1 Corner: 1/8” 5/21/2009 PMS 151 PMS 1555 PMS 185 Black Bar Code: GS1 Data Bar (Limited 25/3) Multi-Color Pharmacode (67): Pr...

custom-source

2025-02-12T13:44:06.891511

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 165}

10,953

Heparin Sodium Injection, USP Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, ...

custom-source

2025-02-12T13:44:07.045437

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 168}

10,954

Heparin Sodium Injection, USP Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) -L-iduronic acid 2-sulfate, (2) ...

custom-source

2025-02-12T13:44:07.158115

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 169}

10,951

NDA 17-037/S-158 Page 3 Heparin Sodium Injection, USP Rx only DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2...

custom-source

2025-02-12T13:44:07.196104

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 158}

10,955

CEBERT PHARMACEUTICALS, INC. DISKETS® Dispersible Tablets CII (Methadone Hydrochloride Tablets, USP), 40 mg Rx only FOR ORAL USE ONLY (Following Dispersion in a Liquid) Deaths have been reported during initiation of methadone treatment for opioid dependence. In some cases, drug interactions with other drugs...

custom-source

2025-02-12T13:44:07.486701

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf', 'application_number': 17058, 'submission_type': 'SUPPL ', 'submission_number': 17}

10,956

...

custom-source

2025-02-12T13:44:07.666734

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf', 'application_number': 17058, 'submission_type': 'SUPPL ', 'submission_number': 21}

10,957

1 DX:L57 PRESCRIBING INFORMATION DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained-release capsules and Tablets WARNING AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION...

custom-source

2025-02-12T13:44:07.704350

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 40}

10,958

DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained release capsules Cll Rx Only WARNING: AMPHETAMINES HAVE A HIGH POTENTIAL FOR...

custom-source

2025-02-12T13:44:07.707761

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 46}

10,960

DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained release capsules Cll Rx Only WARNING: AMPHETAMINES HAVE A HIGH POTENTIAL FOR...

custom-source

2025-02-12T13:44:07.974202

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 48}

10,961

NDA 17-084/S-017 Page 3 Product info This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda NDA 17-084/S-017 Page 4 Phosphocol® P 32 Chromic Phosphate P 32 S...

custom-source

2025-02-12T13:44:08.000542

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017084s017lbl.pdf', 'application_number': 17084, 'submission_type': 'SUPPL ', 'submission_number': 17}

10,959

structural formula DEXEDRINE® (dextroamphetamine sulfate) SPANSULE® sustained release capsules Cll Rx Only WARNING: AMPHETAMINES HAVE A H...

custom-source

2025-02-12T13:44:08.175886

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf', 'application_number': 17078, 'submission_type': 'SUPPL ', 'submission_number': 47}

10,962

NDA 17-087/S-047 Page 3 ĒTHRANE (enflurane, USP) Liquid For Inhalation Rx only DESCRIPTION ĒTHRANE (enflurane, USP), a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is 2-chloro-1,1,2-trifluoroethyl difluoromethyl ether (CHF2OCF2CHFCl). The boiling point is 56.5º...

custom-source

2025-02-12T13:44:08.178467

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf', 'application_number': 17087, 'submission_type': 'SUPPL ', 'submission_number': 47}

10,963

Ethrane® (enflurane, USP) Page 1 of 9 ĒTHRANE (enflurane, USP) Liquid For Inhalation Rx only DESCRIPTION ĒTHRANE (enflurane, USP), a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is 2-chloro-1,1,2-trifluoroethyl difluoromethyl ether (CHF2OCF2C...

custom-source

2025-02-12T13:44:08.245944

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf', 'application_number': 17087, 'submission_type': 'SUPPL ', 'submission_number': 48}

10,964

Page 1 of 15 Tofranil-PM® imipramine pamoate capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, ado...

custom-source

2025-02-12T13:44:08.342645

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 74}

10,966

Tofranil-PM™ (imipramine pamoate) capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidali...

custom-source

2025-02-12T13:44:08.631289

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 77}

10,967

Tofranil-PM™ (imipramine pamoate) capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking ...

custom-source

2025-02-12T13:44:08.665772

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 78}

10,965

s t r uctural formula Tofranil-PM™ (imipramine pamoate) capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx only Prescribing Information Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and be...

custom-source

2025-02-12T13:44:08.730786

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf', 'application_number': 17090, 'submission_type': 'SUPPL ', 'submission_number': 76}

10,968

TRANXENE* T-TAB® Tablets clorazepate dipotassium tablets, USP Rx only DESCRIPTION Chemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4-Benzodiazepine-3-carboxyl...

custom-source

2025-02-12T13:44:08.885460

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf', 'application_number': 17105, 'submission_type': 'SUPPL ', 'submission_number': 75}

10,970

company logo ® MOBAN (Molindone Hydrochloride Tablets, USP) Rx only WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen ...

custom-source

2025-02-12T13:44:08.991893

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017111s067lbl.pdf', 'application_number': 17111, 'submission_type': 'SUPPL ', 'submission_number': 67}

10,971

NDA 17-116/S-015 NDA 17-116/S-016 Page 3 CII Methadose® Oral Concentrate (methadone hydrochloride oral concentrate USP) and Methadose® Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored Rx only FOR ORAL USE ONLY CONDITIONS FOR DISTRIBUTION A...

custom-source

2025-02-12T13:44:09.260503

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf', 'application_number': 17116, 'submission_type': 'SUPPL ', 'submission_number': 15}

10,969

Tranxene* T-TAB® Tablets (clorazepate dipotassium tablets, USP) Rx only DESCRIPTION Chemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4-Benzodiazepine-3-carbo...

custom-source

2025-02-12T13:44:09.337020

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf', 'application_number': 17105, 'submission_type': 'SUPPL ', 'submission_number': 76}

10,973

Page 1 Ultra-TechneKow® DTE (Technetium Tc 99m Generator) Rx Only For the Production of Sodium Pertechnetate To 99m Injection DESCRIPTION: The Ultra-TechneKow® DTE Generator is prepared with fission-produced molybdenum Mo 99 adsorbed onto alumina in a lead shielded column. This generator provides a closed sys...

custom-source

2025-02-12T13:44:09.388206

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf', 'application_number': 17243, 'submission_type': 'SUPPL ', 'submission_number': 25}

10,972

CIV DARVOCET-N® 50 and DARVOCET-N® 100 (PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP) Rx only WARNINGS • There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcoho...

custom-source

2025-02-12T13:44:09.419422

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf', 'application_number': 17122, 'submission_type': 'SUPPL ', 'submission_number': 62}

10,975

RETIN-A® Cream Gel Liquid (tretinoin) For Topical Use Only Prescribing Information Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ...

custom-source

2025-02-12T13:44:09.566774

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 17340, 'submission_type': 'SUPPL ', 'submission_number': 32}

10,974

515083-0811 August 2011 XENON Xe 133 GAS FOR DIAGNOSTIC USE DESCRIPTION: Xenon Xe 133 Gas is supplied in a mixture of xenon gas (5%) in carbon dioxide (95%). It is contained within septum sealed glass vials and is suitable for inhalation...

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2025-02-12T13:44:09.627681

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017284s012lbl.pdf', 'application_number': 17284, 'submission_type': 'SUPPL ', 'submission_number': 12}

10,977

Rx only BACTRIM™ sulfamethoxazole and trimethoprim DS (double strength) tablets and tablets USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethox...

custom-source

2025-02-12T13:44:09.698730

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf', 'application_number': 17377, 'submission_type': 'SUPPL ', 'submission_number': 68}

10,976

only BACTRIM™ brand of sulfamethoxazole and trimethoprim DS (double strength) TABLETS and TABLETS, USP DESCRIPTION BACTRIM (sulfamethoxazole and trimethoprim) is a syn- thetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sul- famethoxazole and 160 mg trimethopr...

custom-source

2025-02-12T13:44:09.815552

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf', 'application_number': 17377, 'submission_type': 'SUPPL ', 'submission_number': 58}

10,978

Rx only BACTRIM™ sulfamethoxazole and trimethoprim DS (double strength) tablets and tablets USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethox...

custom-source

2025-02-12T13:44:09.899489

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf', 'application_number': 17377, 'submission_type': 'SUPPL ', 'submission_number': 73}

10,981

NDA 16-324/S-031 NDA 17-391/S-014 Page 3 PRODUCT INFORMATION Imuran® (azathioprine) 50-mg Scored Tablets 100 mg (as the sodium salt) for I.V. injection, Equivalent to 100 mg azathioprine sterile lyophilized mate...

custom-source

2025-02-12T13:44:10.042383

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016324s031,017391s014lbl.pdf', 'application_number': 17391, 'submission_type': 'SUPPL ', 'submission_number': 14}

10,979

07-19-51-797 Baxter PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in AVIVA Plastic Container DESCRIPTION PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration...

custom-source

2025-02-12T13:44:10.253471

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf', 'application_number': 17378, 'submission_type': 'SUPPL ', 'submission_number': 65}

10,983

Catapres® (clonidine hydrochloride, USP) Boehringer Ingelheim Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information DESCRIPTION Catapres® (clonidine hydrochloride, USP) is a centrally acting alpha-agonist hypotensive agent available as tablets for oral admi...

custom-source

2025-02-12T13:44:10.325632

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf', 'application_number': 17407, 'submission_type': 'SUPPL ', 'submission_number': 34}

10,980

NDA 16-324/S-030 NDA 17-391/S-013 Page 3 PRODUCT INFORMATION IMURAN® (azathioprine) 518700 50-mg Scored Tablets ...

custom-source

2025-02-12T13:44:10.327202

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016324s030,017391s013lbl.pdf', 'application_number': 17391, 'submission_type': 'SUPPL ', 'submission_number': 13}

10,982

NDA 17-398/S-015 Page 3 PACKAGE INSERT REGONOL® (pyridostigmine bromide injection USP) CONTAINS BENZYL ALCOHOL THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS. DESCRIPTION REGONOL® (pyridostigmine bromide injection USP) is an ac...

custom-source

2025-02-12T13:44:10.340572

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf', 'application_number': 17398, 'submission_type': 'SUPPL ', 'submission_number': 15}

10,985

s t ru ct ura l f or mu la Catapres® (clonidine hydrochloride, USP) company logo Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Rx only Prescribing Information DESCRIPTION Catapres® (clonidine hydrochloride, USP) is a centrally acting alpha-agonist hypotensive agent available as tablets ...

custom-source

2025-02-12T13:44:10.639673

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf', 'application_number': 17407, 'submission_type': 'SUPPL ', 'submission_number': 37}