HenriLD/FDA_Docs · Datasets at Hugging Face

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14,766	NDA 21-257/S-006 NDA 21-257/S-008 NDA 21-257/S-009 Page 3 TRAVATAN® (travoprost ophthalmic solution) 0.004% Sterile DESCRIPTION Travoprost is a synthetic prostaglandin F2α analogue. Its chemical name is isopropyl (Z)-7- [(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-4-[(α,α,α- trifluoro-m-tolyl)oxy]-l- buten...	custom-source	2025-02-12T13:53:35.548084	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 9}
14,767	NDA 21-257/S-010 Page 3 TRAVATAN® (travoprost ophthalmic solution) 0.004% Sterile DESCRIPTION Travoprost is a synthetic prostaglandin F2α analogue. Its chemical name is isopropyl (Z)-7- [(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-4-[(α,α,α- trifluoro-m-tolyl)oxy]-l- butenyl]cyclopentyl]-5-heptenoate. It has...	custom-source	2025-02-12T13:53:35.726024	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21257scp010travatan_lbl.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 10}
14,770	METADATE CD EXTENDED-RELEASE CAPSULES FINAL DRAFT APPROVED LABELING ATTACHMENT TO APPROVAL LETTER Once Daily Metadate® CD (methylphenidate HCl, USP) Extended-Release Capsules CII Rx Only R549 Rev. XX/XX DESCRIPTION: METADATE CD is a central nervous system (CNS) stimulant. METADATE CD contains 20 mg of me...	custom-source	2025-02-12T13:53:35.975520	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf', 'application_number': 21259, 'submission_type': 'ORIG ', 'submission_number': 1}
14,769	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	2025-02-12T13:53:36.097325	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 15}
14,768	NDA 21-257/S-012 NDA 21-257/S-013 Page 3 5 ML FILL CONTAINER AND CARTON LABELING: This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda NDA 21-257/S-012 NDA 21-257/S-013 Page 4 PACKAGE INSERT LABELING: TRAVATAN® (...	custom-source	2025-02-12T13:53:36.118700	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 12}
14,772	Once Daily Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component ...	custom-source	2025-02-12T13:53:36.420325	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 20}
14,771	1 METADATE   CD EXTENDED-RELEASE CAPSULES ATTACHMENT TO NDA 21-259/S-001 APPROVAL LETTER Once Daily Metadate® CD (methylphenidate HCl, USP) Extended-Release Capsules CII Rx Only R549B Rev. XX/XX 1/02 DESCRIPTION: METADATE CD is a central nervous system (CNS) stimulant. METADATE CD contains 20 mg of methylpheni...	custom-source	2025-02-12T13:53:36.619438	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 1}
14,773	Once Daily Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provi...	custom-source	2025-02-12T13:53:36.679539	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 22}
14,774	Once Daily Metadate CD® company logo (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the d...	custom-source	2025-02-12T13:53:36.930622	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 26}
14,778	Page 3 NDA 20-490/S-007 NDA 20-613/S-018 NDA 21-262/S-006 ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.5% Sterile DESCRIPTION ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.5% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of bri...	custom-source	2025-02-12T13:53:37.358514	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf', 'application_number': 21262, 'submission_type': 'SUPPL ', 'submission_number': 6}
14,775	Once Daily Metadate CD® company logo (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the d...	custom-source	2025-02-12T13:53:37.397377	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 27}
14,779	NDA 21-262/S-018 Page 3 ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15% Sterile DESCRIPTION ALPHAGAN® P (brimonidine tartrate ophthalmic solution) is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2- imida...	custom-source	2025-02-12T13:53:37.820009	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf', 'application_number': 21262, 'submission_type': 'SUPPL ', 'submission_number': 18}
14,777	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the...	custom-source	2025-02-12T13:53:37.833942	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015lbl.pdf', 'application_number': 21260, 'submission_type': 'SUPPL ', 'submission_number': 15}
14,780	_________ ______ _____ __________ ______ ___________ ___________ ______ ________________________________________________________________________________________________________ ...	custom-source	2025-02-12T13:53:37.871513	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf', 'application_number': 21262, 'submission_type': 'SUPPL ', 'submission_number': 20}
14,776	AVINZA™ (morphine sulfate) Extended-Release Capsules 30mg, 60mg, 90mg and 120mg New Drug Application # 21-260 ELAN PHARMACEUTICAL RESEARCH CORPORATION C:\dmautop\temp\N 21-260 label with PPI final 3-20-02 for AP.doc AVINZA™ 1 (morphine sulfate extended-release capsules) 2 CII 3 Rx Only 4 WARNING: ...	custom-source	2025-02-12T13:53:37.977906	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21260lbl.pdf', 'application_number': 21260, 'submission_type': 'ORIG ', 'submission_number': 1}
14,783	---------- ...	custom-source	2025-02-12T13:53:38.393961	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf', 'application_number': 21265, 'submission_type': 'SUPPL ', 'submission_number': 15}
14,782	NDA 21-265/S-001 Page 3 For dilution in intravenous infusions only INFUVITE Pediatric Multiple Vitamins for Infusion INFUVITE Pediatric Multiple Vitamins for Infusion DESCRIPTION INFUVITE Pediatric is a sterile product consisting of two vials: a 4 mL single-dose vial labeled Vial 1 and a 1 mL single-dose vial label...	custom-source	2025-02-12T13:53:38.396432	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21265s1lbl.pdf', 'application_number': 21265, 'submission_type': 'SUPPL ', 'submission_number': 1}
14,781	...	custom-source	2025-02-12T13:53:38.834616	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf', 'application_number': 21264, 'submission_type': 'SUPPL ', 'submission_number': 10}
14,784	Version 10.0 Proposed text of labeling - 22May02 revisions incorporated 1 PROPOSED US PACKAGE INSERT PRODUCT NAME VFEND® (voriconazole) Tablets VFEND® I.V. (voriconazole) for Injection Version 22 May 02 DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as film-coated tablets for oral adminis...	custom-source	2025-02-12T13:53:39.013217	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf', 'application_number': 21266, 'submission_type': 'ORIG ', 'submission_number': 1}
14,788	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...	custom-source	2025-02-12T13:53:39.625072	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 10}
14,786	1 69-5906-00-4 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for s...	custom-source	2025-02-12T13:53:40.109750	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 6}
14,785	1 69-5906-00-4 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for s...	custom-source	2025-02-12T13:53:40.112067	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 5}
14,789	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:40.385446	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 12}
14,787	Final Approved USPI 22Dec03 1 69-5906-00- VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, fi...	custom-source	2025-02-12T13:53:40.871380	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 7}
14,792	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:40.937551	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 16}
14,790	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:41.058208	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 13}
14,793	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...	custom-source	2025-02-12T13:53:41.369800	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 19}
14,795	VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...	custom-source	2025-02-12T13:53:41.848346	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 30}
14,794	VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...	custom-source	2025-02-12T13:53:42.296614	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 25}
14,796	________________________________________________________________________________________________________________________ HIG...	custom-source	2025-02-12T13:53:42.645338	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 31}
14,797	________________________________________________________________________________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND. VFEND® (voricona...	custom-source	2025-02-12T13:53:42.665223	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 37}
14,798	...	custom-source	2025-02-12T13:53:42.941295	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 38}
14,799		custom-source	2025-02-12T13:53:42.964627	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_VFEND_prntlbl.pdf', 'application_number': 21267, 'submission_type': 'ORIG ', 'submission_number': 1}
14,803	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...	custom-source	2025-02-12T13:53:43.311318	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 10}
14,801	1 69-5906-00-4 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for s...	custom-source	2025-02-12T13:53:43.732579	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 5}
14,800	1 69-5906-00-1 VFEND® Tablets (voriconazole) VFEND® I.V. (voriconazole) for Injection DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as film-coated tablets for oral administration, and as a lyophilized powder for solution for intravenous infusion. The structural formula is: F F CH3 N N F O...	custom-source	2025-02-12T13:53:43.788271	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 3}
14,802	Final Approved USPI 22Dec03 1 69-5906-00- VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, fi...	custom-source	2025-02-12T13:53:44.108843	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 7}
14,804	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:44.233053	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 11}
14,805	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:44.639856	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 12}
14,807	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:44.666625	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 16}
14,808	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...	custom-source	2025-02-12T13:53:44.859265	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 19}
14,809	1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...	custom-source	2025-02-12T13:53:45.157727	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 24}
14,810	VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...	custom-source	2025-02-12T13:53:45.522711	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 25}
14,813	TEVETEN® HCT (eprosartan mesylate/hydrochlorothiazide)600/12.5mg 600/25mg Rx Only PRESCRIBING INFORMATION USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin- angiotensin system can cause injury and even death to the developing fetu...	custom-source	2025-02-12T13:53:45.729327	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf', 'application_number': 21268, 'submission_type': 'SUPPL ', 'submission_number': 15}
14,811	VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...	custom-source	2025-02-12T13:53:46.027026	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 33}
14,812	________________________________________________________________________________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highligh...	custom-source	2025-02-12T13:53:46.223615	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 37}
14,814	TEVETEN® HCT (eprosartan mesylate/hydrochlorothiazide)600/12.5mg 600/25mg Rx Only PRESCRIBING INFORMATION USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin- angiotensin system can cause injury and even death to the developing fetu...	custom-source	2025-02-12T13:53:46.271127	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf', 'application_number': 21268, 'submission_type': 'SUPPL ', 'submission_number': 16}
14,815	...	custom-source	2025-02-12T13:53:46.402088	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf', 'application_number': 21268, 'submission_type': 'SUPPL ', 'submission_number': 19}
14,816	CARDURA®XL (doxazosin mesylate extended release tablets) 1 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda DESCRIPTION CARDURA XL (doxazosin mesylate extended release tablets) contains doxazosin mesylate which is a quin...	custom-source	2025-02-12T13:53:46.498929	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf', 'application_number': 21269, 'submission_type': 'ORIG ', 'submission_number': 1}
14,817	CARDURA® XL (doxazosin mesylate extended release tablets) DESCRIPTION CARDURA® XL (doxazosin mesylate extended release tablets) contains doxazosin mesylate which is a quinazoline compound with the chemical name 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4 benzodioxan-2-ylcar...	custom-source	2025-02-12T13:53:46.660105	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf', 'application_number': 21269, 'submission_type': 'SUPPL ', 'submission_number': 11}
14,818	...	custom-source	2025-02-12T13:53:46.762375	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf', 'application_number': 21269, 'submission_type': 'SUPPL ', 'submission_number': 17}
14,819	NDA 21-271 Page 3 Iprivask 15 mg [Desirudin for Injection] Rx only SPINAL/EPIDURAL HEMATOMAS When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as Iprivask may be a...	custom-source	2025-02-12T13:53:46.918958	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf', 'application_number': 21271, 'submission_type': 'ORIG ', 'submission_number': 1}
14,820	...	custom-source	2025-02-12T13:53:46.937127	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf', 'application_number': 21271, 'submission_type': 'SUPPL ', 'submission_number': 6}
14,821	NDA 21-272 Page 4 PRODUCT INFORMATION REMODULIN (treprostinil sodium) Injection DESCRIPTION Remodulin (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1.0 mg/mL, 2.5 mg/m...	custom-source	2025-02-12T13:53:47.174571	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf', 'application_number': 21272, 'submission_type': 'ORIG ', 'submission_number': 1}
14,822	NDA 21-272/S-005 Page 3 PRODUCT INFORMATION REMODULIN® (treprostinil sodium) Injection DESCRIPTION Remodulin® (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1 mg/mL,...	custom-source	2025-02-12T13:53:47.285684	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 5}
14,824	PRODUCT INFORMATION REMODULIN® (treprostinil sodium) Injection DESCRIPTION Remodulin® (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 m...	custom-source	2025-02-12T13:53:47.387117	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 9}
14,823	_______________________________________________________________________________________________________________________________________ ...	custom-source	2025-02-12T13:53:47.709674	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 8}
14,826	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FOLLISTIM ® ...	custom-source	2025-02-12T13:53:47.894821	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf', 'application_number': 21273, 'submission_type': 'SUPPL ', 'submission_number': 6}
14,825	_________________________________________________________________________________________________________________________ ...	custom-source	2025-02-12T13:53:48.058805	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 20}
14,827	NDA 21-275 Page 1 LUMIGAN  (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN  (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylh...	custom-source	2025-02-12T13:53:48.097449	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf', 'application_number': 21275, 'submission_type': 'ORIG ', 'submission_number': 1}
14,828	NDA 21-275/S-006 Page 3 LUMIGAN   (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN   (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-penteny...	custom-source	2025-02-12T13:53:48.125962	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 6}
14,831	NDA 21-275/S-013 Page 3 LUMIGAN® (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN® (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-pentenyl]cyclopen...	custom-source	2025-02-12T13:53:48.300626	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 13}
14,830	_____________________________________________________________________________________________________ ___...	custom-source	2025-02-12T13:53:48.342892	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 11}
14,832	NDA 21-275/S-014 NDA 21-275/S-015 Page 3 LUMIGAN (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-p...	custom-source	2025-02-12T13:53:48.431322	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 15}
14,833	NDA 21275/S-026 Page 4 HIGHLIGHTS OF PRESCRIBING INFORMATION _______WARNINGS AND PRECAUTIONS_______ These highlights do not include all the information needed to use  Pigmentation. LUMIGAN® (bimatoprost ophthalmic solution) 0.03% safely and Pigmentation of the iris, periorbital...	custom-source	2025-02-12T13:53:48.541127	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 26}
14,829	NDA 21-275/S-010 NDA 21-275/S-012 Page 3 LUMIGAN (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-p...	custom-source	2025-02-12T13:53:48.622632	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 10}
14,836	AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 2/25/03 DESCRIPTION AVELOX® (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous adm...	custom-source	2025-02-12T13:53:48.820525	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 7}
14,834	1 AVELOX   (moxifloxacin hydrochloride) Tablets AVELOX   (moxifloxacin hydrochloride in sodium chloride injection) I.V. FINAL DRAFT PACKAGE INSERT 11/29/01 DESCRIPTION AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administratio...	custom-source	2025-02-12T13:53:48.898977	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21277lbl.pdf', 'application_number': 21277, 'submission_type': 'ORIG ', 'submission_number': 1}
14,837	AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 08753736, R.6 6/04 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infe...	custom-source	2025-02-12T13:53:49.046866	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 17}
14,838	1 AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 08753736, R. 4 2/04 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be us...	custom-source	2025-02-12T13:53:49.142544	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 18}
14,835	1 AVELOX  (moxifloxacin hydrochloride) Tablets 1 AVELOX  I.V. (moxifloxacin hydrochloride in sodium chloride injection) 2 3 FINAL DRAFT PACKAGE INSERT 5/02 4 5 DESCRIPTION 6 AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and 7 is available as AVELOX Tablets for oral administr...	custom-source	2025-02-12T13:53:49.257362	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 2}
14,842	NDA 21-085/S-042 NDA 21-277/S-036 Page 5 MEDICATION GUIDE AVELOX® (AV-eh-locks) (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (AV-eh-locks) (moxifloxacin hydrochloride in sodium chloride injecti...	custom-source	2025-02-12T13:53:49.685381	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 36}
14,839	AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) XXXXXXXX 6/9 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infections...	custom-source	2025-02-12T13:53:50.039408	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 22}
14,840	AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are prove...	custom-source	2025-02-12T13:53:50.280268	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 24}
14,841	1 1 AVELOX® 2 (moxifloxacin hydrochloride) Tablets 3 AVELOX® I.V. 4 (moxifloxacin hydrochloride in sodium chloride injection) 5 08918409, R X 12/08 WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages....	custom-source	2025-02-12T13:53:50.316960	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 33}
14,843	1 AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 81532312, RX 9/09 WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and...	custom-source	2025-02-12T13:53:50.568457	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 39}
14,844	1 AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 81532312, R3 02/10 WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is...	custom-source	2025-02-12T13:53:51.526217	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 40}
14,846	HIGHLIGHTS OF PRESCRIBING INFORMATION These ...	custom-source	2025-02-12T13:53:51.743942	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 46}
14,847	HIG...	custom-source	2025-02-12T13:53:51.984764	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 52}
14,845	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the i...	custom-source	2025-02-12T13:53:51.991723	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 41}
14,851		custom-source	2025-02-12T13:53:52.748268	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf', 'application_number': 21278, 'submission_type': 'ORIG ', 'submission_number': 1}
14,848	...	custom-source	2025-02-12T13:53:52.806173	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 55}
14,849	...	custom-source	2025-02-12T13:53:53.648834	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 56}
14,850	1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVELOX® safely and effectively. See full prescribing information for AVELOX. AVELOX (moxifloxacin hydrochloride) tablets, for oral use AVELOX (moxifloxacin hydrochloride) injection, for intravenous use Ini...	custom-source	2025-02-12T13:53:53.656597	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 59}
14,852	NDA 21-278/S-004/S-005 Page 3 T2006-64 Focalin® dexmethylphenidate hydrochloride tablets Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-thr...	custom-source	2025-02-12T13:53:53.716055	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 4}
14,853	NDA 21-278/S-004/S-005 Page 3 T2006-64 Focalin® dexmethylphenidate hydrochloride tablets Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-thr...	custom-source	2025-02-12T13:53:53.721694	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 5}
14,855	company logo Focalin® dexmethylphenidate hydrochloride tablets company logo Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is ...	custom-source	2025-02-12T13:53:54.066625	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 16}
14,857	NDA 20-406/S-045 NDA 21-281/S-002 Page 3 (Nos. 1541, 3046, 7309, 7311) XX-XXXX-RXX-Rev. Month, 200x PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension DESCRIPTION The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules and...	custom-source	2025-02-12T13:53:54.343753	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 2}
14,854	T2006-94 Focalin® dexmethylphenidate hydrochloride tablets Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo- enantiomers. Focalin is a central ...	custom-source	2025-02-12T13:53:54.495740	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 7}
14,856	NDA 21-281 Page 4 (Nos. 1541, 3046, 7309, 7311) XX-XXXX-RXX-Rev. Month, 200x PREVACID® (lansoprazole) Delayed-Release Capsules For Delayed-Release Oral Suspension DESCRIPTION The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules and PREVACID (lansoprazole) for Delayed-Release Oral Suspension) is a s...	custom-source	2025-02-12T13:53:54.542627	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf', 'application_number': 21281, 'submission_type': 'ORIG ', 'submission_number': 1}
14,858	NDA 21-428 NDA 20-406/S-052 NDA 21-281/S-007 Page 4 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) TAPDN018-V7- Rev. Month, Year PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTabTM (lansoprazole) Delayed-Release Orally ...	custom-source	2025-02-12T13:53:54.668718	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 7}
14,859	Page 1 of 34 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) 03-5366-R24 Rev. July, 2004 PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTab™ (lansoprazole) Delayed-Release Orally Disintegrating Tablets DESCRIP...	custom-source	2025-02-12T13:53:54.864848	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 14}
14,861	NDA 20-406/S-064 NDA 21-281/S-021 NDA 21-428/S012 Page 3 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) 03-5530-R25, Rev. September 2006 IN-5332/S PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTab™ (lansoprazole...	custom-source	2025-02-12T13:53:55.006667	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 21}
14,862	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	2025-02-12T13:53:55.032405	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21283lbl.pdf', 'application_number': 21283, 'submission_type': 'ORIG ', 'submission_number': 1}
14,860	NDA 20-406/S-058 NDA 21-281/S-017 NDA 21-428/S-006 Page 3 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) TAPDN272-V2 Rev. Month, Year PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTab™ (lansoprazole) Delayed-Release Oral...	custom-source	2025-02-12T13:53:55.290045	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 17}
14,863		custom-source	2025-02-12T13:53:55.328926	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283S002_Diovan_prntlbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 2}
14,865	Diovan® T2006-ProposedMAR Diovan® valsartan Tablets Rx only Prescribing Information USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When preg...	custom-source	2025-02-12T13:53:55.357447	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021283s018lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 18}
14,864	NDA 21-283/S-011 Page 3 T2005-02 Diovan® valsartan Tablets Rx only Prescribing Information USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus...	custom-source	2025-02-12T13:53:55.469085	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021283s011lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 11}
14,866	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information ne...	custom-source	2025-02-12T13:53:55.581735	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 33}
14,867	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996 WARNING: FETAL TOXICITY See full prescribing information for complete box...	custom-source	2025-02-12T13:53:55.800853	{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s037lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 37}

14,766

NDA 21-257/S-006 NDA 21-257/S-008 NDA 21-257/S-009 Page 3 TRAVATAN® (travoprost ophthalmic solution) 0.004% Sterile DESCRIPTION Travoprost is a synthetic prostaglandin F2α analogue. Its chemical name is isopropyl (Z)-7- [(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-4-[(α,α,α- trifluoro-m-tolyl)oxy]-l- buten...

custom-source

2025-02-12T13:53:35.548084

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 9}

14,767

NDA 21-257/S-010 Page 3 TRAVATAN® (travoprost ophthalmic solution) 0.004% Sterile DESCRIPTION Travoprost is a synthetic prostaglandin F2α analogue. Its chemical name is isopropyl (Z)-7- [(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-4-[(α,α,α- trifluoro-m-tolyl)oxy]-l- butenyl]cyclopentyl]-5-heptenoate. It has...

custom-source

2025-02-12T13:53:35.726024

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21257scp010travatan_lbl.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 10}

14,770

METADATE CD EXTENDED-RELEASE CAPSULES FINAL DRAFT APPROVED LABELING ATTACHMENT TO APPROVAL LETTER Once Daily Metadate® CD (methylphenidate HCl, USP) Extended-Release Capsules CII Rx Only R549 Rev. XX/XX DESCRIPTION: METADATE CD is a central nervous system (CNS) stimulant. METADATE CD contains 20 mg of me...

custom-source

2025-02-12T13:53:35.975520

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf', 'application_number': 21259, 'submission_type': 'ORIG ', 'submission_number': 1}

14,769

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

2025-02-12T13:53:36.097325

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 15}

14,768

NDA 21-257/S-012 NDA 21-257/S-013 Page 3 5 ML FILL CONTAINER AND CARTON LABELING: This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda NDA 21-257/S-012 NDA 21-257/S-013 Page 4 PACKAGE INSERT LABELING: TRAVATAN® (...

custom-source

2025-02-12T13:53:36.118700

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf', 'application_number': 21257, 'submission_type': 'SUPPL ', 'submission_number': 12}

14,772

Once Daily Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component ...

custom-source

2025-02-12T13:53:36.420325

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 20}

14,771

1 METADATE   CD EXTENDED-RELEASE CAPSULES ATTACHMENT TO NDA 21-259/S-001 APPROVAL LETTER Once Daily Metadate® CD (methylphenidate HCl, USP) Extended-Release Capsules CII Rx Only R549B Rev. XX/XX 1/02 DESCRIPTION: METADATE CD is a central nervous system (CNS) stimulant. METADATE CD contains 20 mg of methylpheni...

custom-source

2025-02-12T13:53:36.619438

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 1}

14,773

Once Daily Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provi...

custom-source

2025-02-12T13:53:36.679539

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 22}

14,774

Once Daily Metadate CD® company logo (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the d...

custom-source

2025-02-12T13:53:36.930622

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 26}

14,778

Page 3 NDA 20-490/S-007 NDA 20-613/S-018 NDA 21-262/S-006 ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.5% Sterile DESCRIPTION ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.5% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of bri...

custom-source

2025-02-12T13:53:37.358514

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf', 'application_number': 21262, 'submission_type': 'SUPPL ', 'submission_number': 6}

14,775

Once Daily Metadate CD® company logo (methylphenidate HCl, USP) Extended-Release Capsules Rx only DESCRIPTION METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the d...

custom-source

2025-02-12T13:53:37.397377

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf', 'application_number': 21259, 'submission_type': 'SUPPL ', 'submission_number': 27}

14,779

NDA 21-262/S-018 Page 3 ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15% Sterile DESCRIPTION ALPHAGAN® P (brimonidine tartrate ophthalmic solution) is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2- imida...

custom-source

2025-02-12T13:53:37.820009

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf', 'application_number': 21262, 'submission_type': 'SUPPL ', 'submission_number': 18}

14,777

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

custom-source

2025-02-12T13:53:37.833942

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015lbl.pdf', 'application_number': 21260, 'submission_type': 'SUPPL ', 'submission_number': 15}

14,780

_________ ______ _____ __________ ______ ___________ ___________ ______ ________________________________________________________________________________________________________ ...

custom-source

2025-02-12T13:53:37.871513

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf', 'application_number': 21262, 'submission_type': 'SUPPL ', 'submission_number': 20}

14,776

AVINZA™ (morphine sulfate) Extended-Release Capsules 30mg, 60mg, 90mg and 120mg New Drug Application # 21-260 ELAN PHARMACEUTICAL RESEARCH CORPORATION C:\dmautop\temp\N 21-260 label with PPI final 3-20-02 for AP.doc AVINZA™ 1 (morphine sulfate extended-release capsules) 2 CII 3 Rx Only 4 WARNING: ...

custom-source

2025-02-12T13:53:37.977906

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21260lbl.pdf', 'application_number': 21260, 'submission_type': 'ORIG ', 'submission_number': 1}

14,783

---------- ...

custom-source

2025-02-12T13:53:38.393961

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021265s015lbl.pdf', 'application_number': 21265, 'submission_type': 'SUPPL ', 'submission_number': 15}

14,782

NDA 21-265/S-001 Page 3 For dilution in intravenous infusions only INFUVITE Pediatric Multiple Vitamins for Infusion INFUVITE Pediatric Multiple Vitamins for Infusion DESCRIPTION INFUVITE Pediatric is a sterile product consisting of two vials: a 4 mL single-dose vial labeled Vial 1 and a 1 mL single-dose vial label...

custom-source

2025-02-12T13:53:38.396432

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21265s1lbl.pdf', 'application_number': 21265, 'submission_type': 'SUPPL ', 'submission_number': 1}

14,781

...

custom-source

2025-02-12T13:53:38.834616

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf', 'application_number': 21264, 'submission_type': 'SUPPL ', 'submission_number': 10}

14,784

Version 10.0 Proposed text of labeling - 22May02 revisions incorporated 1 PROPOSED US PACKAGE INSERT PRODUCT NAME VFEND® (voriconazole) Tablets VFEND® I.V. (voriconazole) for Injection Version 22 May 02 DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as film-coated tablets for oral adminis...

custom-source

2025-02-12T13:53:39.013217

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf', 'application_number': 21266, 'submission_type': 'ORIG ', 'submission_number': 1}

14,788

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...

custom-source

2025-02-12T13:53:39.625072

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 10}

14,786

1 69-5906-00-4 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for s...

custom-source

2025-02-12T13:53:40.109750

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 6}

14,785

1 69-5906-00-4 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for s...

custom-source

2025-02-12T13:53:40.112067

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 5}

14,789

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:40.385446

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 12}

14,787

Final Approved USPI 22Dec03 1 69-5906-00- VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, fi...

custom-source

2025-02-12T13:53:40.871380

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 7}

14,792

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:40.937551

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 16}

14,790

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:41.058208

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 13}

14,793

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...

custom-source

2025-02-12T13:53:41.369800

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 19}

14,795

VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...

custom-source

2025-02-12T13:53:41.848346

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 30}

14,794

VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...

custom-source

2025-02-12T13:53:42.296614

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 25}

14,796

________________________________________________________________________________________________________________________ HIG...

custom-source

2025-02-12T13:53:42.645338

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 31}

14,797

________________________________________________________________________________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND. VFEND® (voricona...

custom-source

2025-02-12T13:53:42.665223

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 37}

14,798

...

custom-source

2025-02-12T13:53:42.941295

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf', 'application_number': 21266, 'submission_type': 'SUPPL ', 'submission_number': 38}

14,799

custom-source

2025-02-12T13:53:42.964627

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_VFEND_prntlbl.pdf', 'application_number': 21267, 'submission_type': 'ORIG ', 'submission_number': 1}

14,803

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...

custom-source

2025-02-12T13:53:43.311318

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 10}

14,801

1 69-5906-00-4 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for s...

custom-source

2025-02-12T13:53:43.732579

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 5}

14,800

1 69-5906-00-1 VFEND® Tablets (voriconazole) VFEND® I.V. (voriconazole) for Injection DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as film-coated tablets for oral administration, and as a lyophilized powder for solution for intravenous infusion. The structural formula is: F F CH3 N N F O...

custom-source

2025-02-12T13:53:43.788271

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 3}

14,802

Final Approved USPI 22Dec03 1 69-5906-00- VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, fi...

custom-source

2025-02-12T13:53:44.108843

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 7}

14,804

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:44.233053

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 11}

14,805

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:44.639856

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 12}

14,807

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:44.666625

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 16}

14,808

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration...

custom-source

2025-02-12T13:53:44.859265

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 19}

14,809

1 VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administrati...

custom-source

2025-02-12T13:53:45.157727

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 24}

14,810

VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...

custom-source

2025-02-12T13:53:45.522711

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 25}

14,813

TEVETEN® HCT (eprosartan mesylate/hydrochlorothiazide)600/12.5mg 600/25mg Rx Only PRESCRIBING INFORMATION USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin- angiotensin system can cause injury and even death to the developing fetu...

custom-source

2025-02-12T13:53:45.729327

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf', 'application_number': 21268, 'submission_type': 'SUPPL ', 'submission_number': 15}

14,811

VFEND® I.V. (voriconazole) for Injection VFEND® Tablets (voriconazole) VFEND® (voriconazole) for Oral Suspension DESCRIPTION VFEND® (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated ...

custom-source

2025-02-12T13:53:46.027026

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 33}

14,812

________________________________________________________________________________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highligh...

custom-source

2025-02-12T13:53:46.223615

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf', 'application_number': 21267, 'submission_type': 'SUPPL ', 'submission_number': 37}

14,814

TEVETEN® HCT (eprosartan mesylate/hydrochlorothiazide)600/12.5mg 600/25mg Rx Only PRESCRIBING INFORMATION USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin- angiotensin system can cause injury and even death to the developing fetu...

custom-source

2025-02-12T13:53:46.271127

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf', 'application_number': 21268, 'submission_type': 'SUPPL ', 'submission_number': 16}

14,815

...

custom-source

2025-02-12T13:53:46.402088

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf', 'application_number': 21268, 'submission_type': 'SUPPL ', 'submission_number': 19}

14,816

CARDURA®XL (doxazosin mesylate extended release tablets) 1 This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda DESCRIPTION CARDURA XL (doxazosin mesylate extended release tablets) contains doxazosin mesylate which is a quin...

custom-source

2025-02-12T13:53:46.498929

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf', 'application_number': 21269, 'submission_type': 'ORIG ', 'submission_number': 1}

14,817

CARDURA® XL (doxazosin mesylate extended release tablets) DESCRIPTION CARDURA® XL (doxazosin mesylate extended release tablets) contains doxazosin mesylate which is a quinazoline compound with the chemical name 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4 benzodioxan-2-ylcar...

custom-source

2025-02-12T13:53:46.660105

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf', 'application_number': 21269, 'submission_type': 'SUPPL ', 'submission_number': 11}

14,818

...

custom-source

2025-02-12T13:53:46.762375

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf', 'application_number': 21269, 'submission_type': 'SUPPL ', 'submission_number': 17}

14,819

NDA 21-271 Page 3 Iprivask 15 mg [Desirudin for Injection] Rx only SPINAL/EPIDURAL HEMATOMAS When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as Iprivask may be a...

custom-source

2025-02-12T13:53:46.918958

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf', 'application_number': 21271, 'submission_type': 'ORIG ', 'submission_number': 1}

14,820

...

custom-source

2025-02-12T13:53:46.937127

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf', 'application_number': 21271, 'submission_type': 'SUPPL ', 'submission_number': 6}

14,821

NDA 21-272 Page 4 PRODUCT INFORMATION REMODULIN (treprostinil sodium) Injection DESCRIPTION Remodulin (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1.0 mg/mL, 2.5 mg/m...

custom-source

2025-02-12T13:53:47.174571

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf', 'application_number': 21272, 'submission_type': 'ORIG ', 'submission_number': 1}

14,822

NDA 21-272/S-005 Page 3 PRODUCT INFORMATION REMODULIN® (treprostinil sodium) Injection DESCRIPTION Remodulin® (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1 mg/mL,...

custom-source

2025-02-12T13:53:47.285684

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 5}

14,824

PRODUCT INFORMATION REMODULIN® (treprostinil sodium) Injection DESCRIPTION Remodulin® (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 m...

custom-source

2025-02-12T13:53:47.387117

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 9}

14,823

_______________________________________________________________________________________________________________________________________ ...

custom-source

2025-02-12T13:53:47.709674

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 8}

14,826

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FOLLISTIM ® ...

custom-source

2025-02-12T13:53:47.894821

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf', 'application_number': 21273, 'submission_type': 'SUPPL ', 'submission_number': 6}

14,825

_________________________________________________________________________________________________________________________ ...

custom-source

2025-02-12T13:53:48.058805

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf', 'application_number': 21272, 'submission_type': 'SUPPL ', 'submission_number': 20}

14,827

NDA 21-275 Page 1 LUMIGAN  (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN  (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylh...

custom-source

2025-02-12T13:53:48.097449

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf', 'application_number': 21275, 'submission_type': 'ORIG ', 'submission_number': 1}

14,828

NDA 21-275/S-006 Page 3 LUMIGAN   (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN   (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-penteny...

custom-source

2025-02-12T13:53:48.125962

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 6}

14,831

NDA 21-275/S-013 Page 3 LUMIGAN® (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN® (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-pentenyl]cyclopen...

custom-source

2025-02-12T13:53:48.300626

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 13}

14,830

_____________________________________________________________________________________________________ ___...

custom-source

2025-02-12T13:53:48.342892

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 11}

14,832

NDA 21-275/S-014 NDA 21-275/S-015 Page 3 LUMIGAN (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-p...

custom-source

2025-02-12T13:53:48.431322

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 15}

14,833

NDA 21275/S-026 Page 4 HIGHLIGHTS OF PRESCRIBING INFORMATION _______WARNINGS AND PRECAUTIONS_______ These highlights do not include all the information needed to use  Pigmentation. LUMIGAN® (bimatoprost ophthalmic solution) 0.03% safely and Pigmentation of the iris, periorbital...

custom-source

2025-02-12T13:53:48.541127

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 26}

14,829

NDA 21-275/S-010 NDA 21-275/S-012 Page 3 LUMIGAN (bimatoprost ophthalmic solution) 0.03% DESCRIPTION LUMIGAN (bimatoprost ophthalmic solution) 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[1E,3S)-3-hydroxy- 5-phenyl-1-p...

custom-source

2025-02-12T13:53:48.622632

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf', 'application_number': 21275, 'submission_type': 'SUPPL ', 'submission_number': 10}

14,836

AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 2/25/03 DESCRIPTION AVELOX® (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous adm...

custom-source

2025-02-12T13:53:48.820525

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 7}

14,834

1 AVELOX   (moxifloxacin hydrochloride) Tablets AVELOX   (moxifloxacin hydrochloride in sodium chloride injection) I.V. FINAL DRAFT PACKAGE INSERT 11/29/01 DESCRIPTION AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administratio...

custom-source

2025-02-12T13:53:48.898977

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21277lbl.pdf', 'application_number': 21277, 'submission_type': 'ORIG ', 'submission_number': 1}

14,837

AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 08753736, R.6 6/04 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infe...

custom-source

2025-02-12T13:53:49.046866

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 17}

14,838

1 AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 08753736, R. 4 2/04 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be us...

custom-source

2025-02-12T13:53:49.142544

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 18}

14,835

1 AVELOX  (moxifloxacin hydrochloride) Tablets 1 AVELOX  I.V. (moxifloxacin hydrochloride in sodium chloride injection) 2 3 FINAL DRAFT PACKAGE INSERT 5/02 4 5 DESCRIPTION 6 AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and 7 is available as AVELOX Tablets for oral administr...

custom-source

2025-02-12T13:53:49.257362

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 2}

14,842

NDA 21-085/S-042 NDA 21-277/S-036 Page 5 MEDICATION GUIDE AVELOX® (AV-eh-locks) (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (AV-eh-locks) (moxifloxacin hydrochloride in sodium chloride injecti...

custom-source

2025-02-12T13:53:49.685381

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 36}

14,839

AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) XXXXXXXX 6/9 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infections...

custom-source

2025-02-12T13:53:50.039408

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 22}

14,840

AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are prove...

custom-source

2025-02-12T13:53:50.280268

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 24}

14,841

1 1 AVELOX® 2 (moxifloxacin hydrochloride) Tablets 3 AVELOX® I.V. 4 (moxifloxacin hydrochloride in sodium chloride injection) 5 08918409, R X 12/08 WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages....

custom-source

2025-02-12T13:53:50.316960

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 33}

14,843

1 AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 81532312, RX 9/09 WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and...

custom-source

2025-02-12T13:53:50.568457

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 39}

14,844

1 AVELOX® (moxifloxacin hydrochloride) Tablets AVELOX® I.V. (moxifloxacin hydrochloride in sodium chloride injection) 81532312, R3 02/10 WARNING: Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is...

custom-source

2025-02-12T13:53:51.526217

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 40}

14,846

HIGHLIGHTS OF PRESCRIBING INFORMATION These ...

custom-source

2025-02-12T13:53:51.743942

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 46}

14,847

HIG...

custom-source

2025-02-12T13:53:51.984764

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 52}

14,845

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

custom-source

2025-02-12T13:53:51.991723

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 41}

14,851

custom-source

2025-02-12T13:53:52.748268

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf', 'application_number': 21278, 'submission_type': 'ORIG ', 'submission_number': 1}

14,848

...

custom-source

2025-02-12T13:53:52.806173

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 55}

14,849

...

custom-source

2025-02-12T13:53:53.648834

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 56}

14,850

1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVELOX® safely and effectively. See full prescribing information for AVELOX. AVELOX (moxifloxacin hydrochloride) tablets, for oral use AVELOX (moxifloxacin hydrochloride) injection, for intravenous use Ini...

custom-source

2025-02-12T13:53:53.656597

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf', 'application_number': 21277, 'submission_type': 'SUPPL ', 'submission_number': 59}

14,852

NDA 21-278/S-004/S-005 Page 3 T2006-64 Focalin® dexmethylphenidate hydrochloride tablets Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-thr...

custom-source

2025-02-12T13:53:53.716055

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 4}

14,853

NDA 21-278/S-004/S-005 Page 3 T2006-64 Focalin® dexmethylphenidate hydrochloride tablets Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-thr...

custom-source

2025-02-12T13:53:53.721694

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 5}

14,855

company logo Focalin® dexmethylphenidate hydrochloride tablets company logo Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is ...

custom-source

2025-02-12T13:53:54.066625

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 16}

14,857

NDA 20-406/S-045 NDA 21-281/S-002 Page 3 (Nos. 1541, 3046, 7309, 7311) XX-XXXX-RXX-Rev. Month, 200x PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension DESCRIPTION The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules and...

custom-source

2025-02-12T13:53:54.343753

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 2}

14,854

T2006-94 Focalin® dexmethylphenidate hydrochloride tablets Rx only Prescribing Information DESCRIPTION Focalin® (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo- enantiomers. Focalin is a central ...

custom-source

2025-02-12T13:53:54.495740

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf', 'application_number': 21278, 'submission_type': 'SUPPL ', 'submission_number': 7}

14,856

NDA 21-281 Page 4 (Nos. 1541, 3046, 7309, 7311) XX-XXXX-RXX-Rev. Month, 200x PREVACID® (lansoprazole) Delayed-Release Capsules For Delayed-Release Oral Suspension DESCRIPTION The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules and PREVACID (lansoprazole) for Delayed-Release Oral Suspension) is a s...

custom-source

2025-02-12T13:53:54.542627

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf', 'application_number': 21281, 'submission_type': 'ORIG ', 'submission_number': 1}

14,858

NDA 21-428 NDA 20-406/S-052 NDA 21-281/S-007 Page 4 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) TAPDN018-V7- Rev. Month, Year PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTabTM (lansoprazole) Delayed-Release Orally ...

custom-source

2025-02-12T13:53:54.668718

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 7}

14,859

Page 1 of 34 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) 03-5366-R24 Rev. July, 2004 PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTab™ (lansoprazole) Delayed-Release Orally Disintegrating Tablets DESCRIP...

custom-source

2025-02-12T13:53:54.864848

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 14}

14,861

NDA 20-406/S-064 NDA 21-281/S-021 NDA 21-428/S012 Page 3 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) 03-5530-R25, Rev. September 2006 IN-5332/S PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTab™ (lansoprazole...

custom-source

2025-02-12T13:53:55.006667

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 21}

14,862

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

2025-02-12T13:53:55.032405

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21283lbl.pdf', 'application_number': 21283, 'submission_type': 'ORIG ', 'submission_number': 1}

14,860

NDA 20-406/S-058 NDA 21-281/S-017 NDA 21-428/S-006 Page 3 (Nos. 1541, 1543, 1544, 3046, 7309, 7311) TAPDN272-V2 Rev. Month, Year PREVACID® (lansoprazole) Delayed-Release Capsules PREVACID® (lansoprazole) For Delayed-Release Oral Suspension PREVACID® SoluTab™ (lansoprazole) Delayed-Release Oral...

custom-source

2025-02-12T13:53:55.290045

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf', 'application_number': 21281, 'submission_type': 'SUPPL ', 'submission_number': 17}

14,863

custom-source

2025-02-12T13:53:55.328926

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283S002_Diovan_prntlbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 2}

14,865

Diovan® T2006-ProposedMAR Diovan® valsartan Tablets Rx only Prescribing Information USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When preg...

custom-source

2025-02-12T13:53:55.357447

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021283s018lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 18}

14,864

NDA 21-283/S-011 Page 3 T2005-02 Diovan® valsartan Tablets Rx only Prescribing Information USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus...

custom-source

2025-02-12T13:53:55.469085

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021283s011lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 11}

14,866

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

custom-source

2025-02-12T13:53:55.581735

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 33}

14,867

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996 WARNING: FETAL TOXICITY See full prescribing information for complete box...

custom-source

2025-02-12T13:53:55.800853

{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s037lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 37}