FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
218230	NDA	GLAXOSMITHKLINE	001	BLUJEPA	TABLET;ORAL	EQ 750MG BASE	GEPOTIDACIN MESYLATE	2025-03-25	Prescription	Yes
216873	NDA	GLAXOSMITHKLINE	001	OJJAARA	TABLET;ORAL	EQ 100MG BASE	MOMELOTINIB DIHYDROCHLORIDE	2023-09-15	Prescription	No
			002	OJJAARA	TABLET;ORAL	EQ 150MG BASE	MOMELOTINIB DIHYDROCHLORIDE	2023-09-15	Prescription	No
			003	OJJAARA	TABLET;ORAL	EQ 200MG BASE	MOMELOTINIB DIHYDROCHLORIDE	2023-09-15	Prescription	Yes
214876	NDA	GLAXOSMITHKLINE	001	ZEJULA	TABLET;ORAL	EQ 100MG BASE	NIRAPARIB TOSYLATE	2023-04-26	Prescription	No
			002	ZEJULA	TABLET;ORAL	EQ 200MG BASE	NIRAPARIB TOSYLATE	2023-04-26	Prescription	No
			003	ZEJULA	TABLET;ORAL	EQ 300MG BASE	NIRAPARIB TOSYLATE	2023-04-26	Prescription	Yes
216951	NDA	GLAXOSMITHKLINE	001	JESDUVROQ	TABLET;ORAL	1MG	DAPRODUSTAT	2023-02-01	Discontinued	No
			002	JESDUVROQ	TABLET;ORAL	2MG	DAPRODUSTAT	2023-02-01	Discontinued	No
			003	JESDUVROQ	TABLET;ORAL	4MG	DAPRODUSTAT	2023-02-01	Discontinued	No
			004	JESDUVROQ	TABLET;ORAL	6MG	DAPRODUSTAT	2023-02-01	Discontinued	No
			005	JESDUVROQ	TABLET;ORAL	8MG	DAPRODUSTAT	2023-02-01	Discontinued	No
761223	BLA	GLAXOSMITHKLINE LLC	001	JEMPERLI	INJECTABLE;INJECTION	500MG/10ML	DOSTARLIMAB-GXLY	2021-08-17	Prescription	No
761174	BLA	GLAXOSMITHKLINE	001	JEMPERLI	INJECTABLE;INJECTION	500MG/10ML	DOSTARLIMAB-GXLY	2021-04-22	Prescription	No
761122	BLA	GLAXOSMITHKLINE	001	NUCALA	INJECTABLE;SUBCUTANEOUS	100MG/ML	MEPOLIZUMAB	2019-06-06	Prescription	No
210795	NDA	GLAXOSMITHKLINE	001	KRINTAFEL	TABLET;ORAL	EQ 150MG BASE	TAFENOQUINE SUCCINATE	2018-07-20	Prescription	Yes
209482	NDA	GLAXOSMITHKLINE	001	TRELEGY ELLIPTA	POWDER;INHALATION	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	2017-09-18	Prescription	Yes
209482	NDA	GLAXOSMITHKLINE	002	TRELEGY ELLIPTA	POWDER;INHALATION	0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	2017-09-18	Prescription	Yes
761043	BLA	GLAXOSMITHKLINE LLC	001	BENLYSTA	INJECTABLE;INJECTION	200MG/ML	BELIMUMAB	2017-07-20	Prescription	No
208447	NDA	GLAXOSMITHKLINE	001	ZEJULA	CAPSULE;ORAL	EQ 100MG BASE	NIRAPARIB TOSYLATE	2017-03-27	Discontinued	No
125526	BLA	GLAXOSMITHKLINE LLC	001	NUCALA	INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER	100MG	MEPOLIZUMAB	2015-11-04	Prescription	No
205625	NDA	GLAXOSMITHKLINE	001	ARNUITY ELLIPTA	POWDER;INHALATION	0.1MG/INH	FLUTICASONE FUROATE	2014-08-20	Prescription	Yes
			002	ARNUITY ELLIPTA	POWDER;INHALATION	0.2MG/INH	FLUTICASONE FUROATE	2014-08-20	Prescription	Yes
			003	ARNUITY ELLIPTA	POWDER;INHALATION	0.05MG/INH	FLUTICASONE FUROATE	2014-08-20	Prescription	Yes
125431	BLA	GLAXOSMITHKLINE LLC	001	TANZEUM	INJECTABLE;INJECTION	30MG	ALBIGLUTIDE	2014-04-15	Discontinued	No
203975	NDA	GLAXOSMITHKLINE	001	ANORO ELLIPTA	POWDER;INHALATION	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	2013-12-18	Prescription	Yes
022345	NDA	GLAXOSMITHKLINE	001	POTIGA	TABLET;ORAL	50MG	EZOGABINE	2011-06-10	Discontinued	No
			002	POTIGA	TABLET;ORAL	200MG	EZOGABINE	2011-06-10	Discontinued	No
			003	POTIGA	TABLET;ORAL	300MG	EZOGABINE	2011-06-10	Discontinued	No
			004	POTIGA	TABLET;ORAL	400MG	EZOGABINE	2011-06-10	Discontinued	No
022115	NDA	GLAXOSMITHKLINE LLC	001	LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	25MG	LAMOTRIGINE	2009-05-29	Prescription	No
			002	LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	50MG	LAMOTRIGINE	2009-05-29	Prescription	Yes
			003	LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	100MG	LAMOTRIGINE	2009-05-29	Prescription	No
			004	LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	200MG	LAMOTRIGINE	2009-05-29	Prescription	Yes
			005	LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	300MG	LAMOTRIGINE	2009-05-29	Prescription	No
			006	LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	250MG	LAMOTRIGINE	2009-05-29	Prescription	No
022251	NDA	GLAXOSMITHKLINE LLC	001	LAMICTAL ODT	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	LAMOTRIGINE	2009-05-08	Prescription	No
			002	LAMICTAL ODT	TABLET, ORALLY DISINTEGRATING;ORAL	50MG	LAMOTRIGINE	2009-05-08	Prescription	Yes
			003	LAMICTAL ODT	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	LAMOTRIGINE	2009-05-08	Prescription	No
			004	LAMICTAL ODT	TABLET, ORALLY DISINTEGRATING;ORAL	200MG	LAMOTRIGINE	2009-05-08	Prescription	No
022008	NDA	GLAXOSMITHKLINE LLC	001	REQUIP XL	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	2008-06-13	Discontinued	No
			002	REQUIP XL	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	2008-06-13	Discontinued	No
			003	REQUIP XL	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	2008-06-13	Discontinued	No
			004	REQUIP XL	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	2008-06-13	Discontinued	No
			005	REQUIP XL	TABLET, EXTENDED RELEASE;ORAL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	2008-06-13	Discontinued	No
			006	REQUIP XL	TABLET, EXTENDED RELEASE;ORAL	EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	2008-06-13	Discontinued	No
077656	ANDA	GLAXOSMITHKLINE CONS	001	THRIVE	GUM, CHEWING;BUCCAL	EQ 4MG BASE	NICOTINE POLACRILEX	2007-06-19	Discontinued	No
077658	ANDA	GLAXOSMITHKLINE CONS	001	THRIVE	GUM, CHEWING;BUCCAL	EQ 2MG BASE	NICOTINE POLACRILEX	2007-06-19	Discontinued	No
021416	NDA	GLAXOSMITHKLINE LLC	001	RYTHMOL SR	CAPSULE, EXTENDED RELEASE;ORAL	225MG	PROPAFENONE HYDROCHLORIDE	2003-09-04	Discontinued	No
			002	RYTHMOL SR	CAPSULE, EXTENDED RELEASE;ORAL	325MG	PROPAFENONE HYDROCHLORIDE	2003-09-04	Discontinued	No
			003	RYTHMOL SR	CAPSULE, EXTENDED RELEASE;ORAL	425MG	PROPAFENONE HYDROCHLORIDE	2003-09-04	Discontinued	No
075822	ANDA	GLAXOSMITHKLINE	001	LORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	LORATADINE	2003-02-10	Discontinued	No
020983	NDA	GLAXOSMITHKLINE	001	VENTOLIN HFA	AEROSOL, METERED;INHALATION	EQ 0.09MG BASE/INH	ALBUTEROL SULFATE	2001-04-19	Prescription	Yes
021078	NDA	GLAXOSMITHKLINE	001	MALARONE	TABLET;ORAL	250MG;100MG	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	2000-07-14	Prescription	Yes
021078	NDA	GLAXOSMITHKLINE	002	MALARONE PEDIATRIC	TABLET;ORAL	62.5MG;25MG	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	2000-07-14	Prescription	No
021019	NDA	GLAXOSMITHKLINE	001	COMPAZINE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 10MG BASE	PROCHLORPERAZINE MALEATE	1999-10-06	Discontinued	No
021019	NDA	GLAXOSMITHKLINE	002	COMPAZINE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE	PROCHLORPERAZINE MALEATE	1999-10-06	Discontinued	No
021036	NDA	GLAXOSMITHKLINE	001	RELENZA	POWDER;INHALATION	5MG	ZANAMIVIR	1999-07-26	Prescription	Yes
020951	NDA	GLAXOSMITHKLINE	001	TAGAMET HB 200	SUSPENSION;ORAL	200MG/20ML	CIMETIDINE	1999-07-09	Discontinued	No
021007	NDA	GLAXOSMITHKLINE	001	AGENERASE	CAPSULE;ORAL	50MG	AMPRENAVIR	1999-04-15	Discontinued	No
021007	NDA	GLAXOSMITHKLINE	002	AGENERASE	CAPSULE;ORAL	150MG	AMPRENAVIR	1999-04-15	Discontinued	No
021039	NDA	GLAXOSMITHKLINE	001	AGENERASE	SOLUTION;ORAL	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMPRENAVIR	1999-04-15	Discontinued	No
021003	NDA	GLAXOSMITHKLINE	001	EPIVIR-HBV	TABLET;ORAL	100MG	LAMIVUDINE	1998-12-08	Discontinued	No
021004	NDA	GLAXOSMITHKLINE	001	EPIVIR-HBV	SOLUTION;ORAL	5MG/ML	LAMIVUDINE	1998-12-08	Discontinued	No
020764	NDA	GLAXOSMITHKLINE LLC	001	LAMICTAL CD	TABLET, FOR SUSPENSION;ORAL	5MG	LAMOTRIGINE	1998-08-24	Prescription	No
			002	LAMICTAL CD	TABLET, FOR SUSPENSION;ORAL	25MG	LAMOTRIGINE	1998-08-24	Prescription	Yes
			003	LAMICTAL CD	TABLET, FOR SUSPENSION;ORAL	100MG	LAMOTRIGINE	1998-08-24	Discontinued	No
			004	LAMICTAL CD	TABLET, FOR SUSPENSION;ORAL	2MG	LAMOTRIGINE	1998-08-24	Prescription	No
020763	NDA	GLAXOSMITHKLINE LLC	001	AMERGE	TABLET;ORAL	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NARATRIPTAN HYDROCHLORIDE	1998-02-10	Discontinued	No
020763	NDA	GLAXOSMITHKLINE LLC	002	AMERGE	TABLET;ORAL	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NARATRIPTAN HYDROCHLORIDE	1998-02-10	Discontinued	No
050746	NDA	GLAXOSMITHKLINE	001	BACTROBAN	CREAM;TOPICAL	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MUPIROCIN CALCIUM	1997-12-11	Discontinued	No
020549	NDA	GLAXOSMITHKLINE	001	FLOVENT	POWDER;INHALATION	0.044MG/INH	FLUTICASONE PROPIONATE	1997-11-07	Discontinued	No
			002	FLOVENT	POWDER;INHALATION	0.088MG/INH	FLUTICASONE PROPIONATE	1997-11-07	Discontinued	No
			003	FLOVENT	POWDER;INHALATION	0.22MG/INH	FLUTICASONE PROPIONATE	1997-11-07	Discontinued	No
020692	NDA	GLAXOSMITHKLINE	001	SEREVENT	POWDER;INHALATION	EQ 0.05MG BASE/INH	SALMETEROL XINAFOATE	1997-09-19	Prescription	Yes
020658	NDA	GLAXOSMITHKLINE LLC	001	REQUIP	TABLET;ORAL	EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
			002	REQUIP	TABLET;ORAL	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
			003	REQUIP	TABLET;ORAL	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
			004	REQUIP	TABLET;ORAL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
			005	REQUIP	TABLET;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
			006	REQUIP	TABLET;ORAL	EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
			007	REQUIP	TABLET;ORAL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ROPINIROLE HYDROCHLORIDE	1997-09-19	Discontinued	No
020626	NDA	GLAXOSMITHKLINE	001	IMITREX	SPRAY;NASAL	5MG/SPRAY	SUMATRIPTAN	1997-08-26	Prescription	Yes
			002	IMITREX	SPRAY;NASAL	10MG/SPRAY	SUMATRIPTAN	1997-08-26	Discontinued	No
			003	IMITREX	SPRAY;NASAL	20MG/SPRAY	SUMATRIPTAN	1997-08-26	Prescription	Yes
020711	NDA	GLAXOSMITHKLINE	002	ZYBAN	TABLET, EXTENDED RELEASE;ORAL	100MG	BUPROPION HYDROCHLORIDE	1997-05-14	Discontinued	No
020711	NDA	GLAXOSMITHKLINE	003	ZYBAN	TABLET, EXTENDED RELEASE;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BUPROPION HYDROCHLORIDE	1997-05-14	Discontinued	No
020358	NDA	GLAXOSMITHKLINE	001	WELLBUTRIN SR	TABLET, EXTENDED RELEASE;ORAL	50MG	BUPROPION HYDROCHLORIDE	1996-10-04	Discontinued	No
			002	WELLBUTRIN SR	TABLET, EXTENDED RELEASE;ORAL	100MG	BUPROPION HYDROCHLORIDE	1996-10-04	Prescription	No
			003	WELLBUTRIN SR	TABLET, EXTENDED RELEASE;ORAL	150MG	BUPROPION HYDROCHLORIDE	1996-10-04	Prescription	No
			004	WELLBUTRIN SR	TABLET, EXTENDED RELEASE;ORAL	200MG	BUPROPION HYDROCHLORIDE	1996-10-04	Prescription	Yes
020548	NDA	GLAXOSMITHKLINE	001	FLOVENT	AEROSOL, METERED;INHALATION	0.044MG/INH	FLUTICASONE PROPIONATE	1996-03-27	Discontinued	No
			002	FLOVENT	AEROSOL, METERED;INHALATION	0.11MG/INH	FLUTICASONE PROPIONATE	1996-03-27	Discontinued	No
			003	FLOVENT	AEROSOL, METERED;INHALATION	0.22MG/INH	FLUTICASONE PROPIONATE	1996-03-27	Discontinued	No
020550	NDA	GLAXOSMITHKLINE	001	VALTREX	Tablet; Oral	EQ 500MG BASE	VALACYCLOVIR HYDROCHLORIDE	1995-12-15	Prescription	No
020550	NDA	GLAXOSMITHKLINE	002	VALTREX	TABLET; ORAL	EQ 1GM BASE	VALACYCLOVIR HYDROCHLORIDE	1995-12-15	Prescription	No
020444	NDA	GLAXOSMITHKLINE LLC	001	FLOLAN	INJECTABLE;INJECTION	EQ 0.5MG BASE/VIAL	EPOPROSTENOL SODIUM	1995-09-20	Prescription	Yes
020444	NDA	GLAXOSMITHKLINE LLC	002	FLOLAN	INJECTABLE;INJECTION	EQ 1.5MG BASE/VIAL	EPOPROSTENOL SODIUM	1995-09-20	Prescription	Yes
050703	NDA	GLAXOSMITHKLINE	001	BACTROBAN	OINTMENT;NASAL	EQ 2% BASE	MUPIROCIN CALCIUM	1995-09-18	Discontinued	No
020487	NDA	GLAXOSMITHKLINE	001	VALTREX	TABLET;ORAL	EQ 500MG BASE	VALACYCLOVIR HYDROCHLORIDE	1995-06-23	Prescription	No
020487	NDA	GLAXOSMITHKLINE	002	VALTREX	TABLET;ORAL	EQ 1GM BASE	VALACYCLOVIR HYDROCHLORIDE	1995-06-23	Prescription	Yes
020132	NDA	GLAXOSMITHKLINE	001	IMITREX	TABLET;ORAL	EQ 100MG BASE	SUMATRIPTAN SUCCINATE	1995-06-01	Prescription	Yes
			002	IMITREX	TABLET;ORAL	EQ 25MG BASE	SUMATRIPTAN SUCCINATE	1995-06-01	Prescription	No
			003	IMITREX	TABLET;ORAL	EQ 50MG BASE	SUMATRIPTAN SUCCINATE	1995-06-01	Prescription	No
020500	NDA	GLAXOSMITHKLINE LLC	001	MEPRON	SUSPENSION;ORAL	750MG/5ML	ATOVAQUONE	1995-02-08	Prescription	Yes
020403	NDA	GLAXOSMITHKLINE	001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ONDANSETRON HYDROCHLORIDE	1995-01-31	Discontinued	No
020241	NDA	GLAXOSMITHKLINE LLC	001	LAMICTAL	TABLET;ORAL	100MG	LAMOTRIGINE	1994-12-27	Prescription	No
			002	LAMICTAL	TABLET;ORAL	150MG	LAMOTRIGINE	1994-12-27	Prescription	No
			003	LAMICTAL	TABLET;ORAL	200MG	LAMOTRIGINE	1994-12-27	Prescription	No
			004	LAMICTAL	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LAMOTRIGINE	1994-12-27	Discontinued	No
			005	LAMICTAL	TABLET;ORAL	25MG	LAMOTRIGINE	1994-12-27	Prescription	Yes
			006	LAMICTAL	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LAMOTRIGINE	1994-12-27	Discontinued	No
050672	NDA	GLAXOSMITHKLINE	001	CEFTIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	CEFUROXIME AXETIL	1994-06-30	Discontinued	No
050672	NDA	GLAXOSMITHKLINE	002	CEFTIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	CEFUROXIME AXETIL	1994-06-30	Discontinued	No
020336	NDA	GLAXOSMITHKLINE LLC	001	DYNACIRC CR	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ISRADIPINE	1994-06-01	Discontinued	No
020336	NDA	GLAXOSMITHKLINE LLC	002	DYNACIRC CR	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ISRADIPINE	1994-06-01	Discontinued	No
020095	NDA	GLAXOSMITHKLINE	001	ZANTAC 150	CAPSULE;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RANITIDINE HYDROCHLORIDE	1994-03-08	Discontinued	No
020095	NDA	GLAXOSMITHKLINE	002	ZANTAC 300	CAPSULE;ORAL	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RANITIDINE HYDROCHLORIDE	1994-03-08	Discontinued	No
020236	NDA	GLAXOSMITHKLINE	001	SEREVENT	AEROSOL, METERED;INHALATION	EQ 0.021MG BASE/INH	SALMETEROL XINAFOATE	1994-02-04	Discontinued	No
064033	ANDA	GLAXOSMITHKLINE	001	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	CEFAZOLIN SODIUM	1993-10-31	Discontinued	No
063295	ANDA	GLAXOSMITHKLINE	001	MONOCID	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	CEFONICID SODIUM	1993-07-26	Discontinued	No
020080	NDA	GLAXOSMITHKLINE	001	IMITREX	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUMATRIPTAN SUCCINATE	1992-12-28	Discontinued	No
			002	IMITREX STATDOSE	INJECTABLE;SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	SUMATRIPTAN SUCCINATE	1992-12-28	Prescription	Yes
			003	IMITREX STATDOSE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	SUMATRIPTAN SUCCINATE	1992-12-28	Prescription	Yes
020259	NDA	GLAXOSMITHKLINE LLC	001	MEPRON	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ATOVAQUONE	1992-11-25	Discontinued	No
020250	NDA	GLAXOSMITHKLINE	001	HALFAN	TABLET;ORAL	250MG	HALOFANTRINE HYDROCHLORIDE	1992-07-24	Discontinued	No
019773	NDA	GLAXOSMITHKLINE	001	VENTOLIN	SOLUTION;INHALATION	EQ 0.083% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ALBUTEROL SULFATE	1992-04-23	Discontinued	No
050646	NDA	GLAXOSMITHKLINE	001	CEPTAZ	INJECTABLE;INJECTION	500MG/VIAL	CEFTAZIDIME	1990-09-27	Discontinued	No
			002	CEPTAZ	INJECTABLE;INJECTION	1GM/VIAL	CEFTAZIDIME	1990-09-27	Discontinued	No
			003	CEPTAZ	INJECTABLE;INJECTION	2GM/VIAL	CEFTAZIDIME	1990-09-27	Discontinued	No
			004	CEPTAZ	INJECTABLE;INJECTION	10GM/VIAL	CEFTAZIDIME	1990-09-27	Discontinued	No
020044	NDA	GLAXOSMITHKLINE	001	EXOSURF NEONATAL	FOR SUSPENSION;INTRATRACHEAL	12MG/VIAL;108MG/VIAL;8MG/VIAL	CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL	1990-08-02	Discontinued	No
050658	NDA	GLAXOSMITHKLINE	001	TIMENTIN IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 100MG BASE/100ML;EQ 3GM BASE/100ML	CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM	1989-12-15	Discontinued	No
019151	NDA	GLAXOSMITHKLINE LLC	001	RYTHMOL	TABLET;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROPAFENONE HYDROCHLORIDE	1989-11-27	Discontinued	No
			002	RYTHMOL	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROPAFENONE HYDROCHLORIDE	1989-11-27	Discontinued	No
			003	RYTHMOL	TABLET;ORAL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROPAFENONE HYDROCHLORIDE	1989-11-27	Discontinued	No
019489	NDA	GLAXOSMITHKLINE	001	VENTOLIN ROTACAPS	CAPSULE;INHALATION	EQ 0.2MG BASE	ALBUTEROL SULFATE	1988-05-04	Discontinued	No
050591	NDA	GLAXOSMITHKLINE	001	BACTROBAN	OINTMENT;TOPICAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MUPIROCIN	1987-12-31	Discontinued	No
050605	NDA	GLAXOSMITHKLINE	001	CEFTIN	TABLET;ORAL	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFUROXIME AXETIL	1987-12-28	Discontinued	No
			002	CEFTIN	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFUROXIME AXETIL	1987-12-28	Discontinued	No
			003	CEFTIN	TABLET;ORAL	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFUROXIME AXETIL	1987-12-28	Discontinued	No
019389	NDA	GLAXOSMITHKLINE	001	BECONASE AQ	SPRAY, METERED;NASAL	EQ 0.042MG DIPROP/SPRAY	BECLOMETHASONE DIPROPIONATE MONOHYDRATE	1987-07-27	Discontinued	No
019621	NDA	GLAXOSMITHKLINE	001	VENTOLIN	SYRUP;ORAL	EQ 2MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ALBUTEROL SULFATE	1987-06-10	Discontinued	No
019269	NDA	GLAXOSMITHKLINE	002	VENTOLIN	SOLUTION;INHALATION	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ALBUTEROL SULFATE	1987-01-16	Discontinued	No
062736	ANDA	GLAXOSMITHKLINE	001	BACTOCILL	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1986-12-19	Discontinued	No
062736	ANDA	GLAXOSMITHKLINE	002	BACTOCILL	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1986-12-19	Discontinued	No
062755	ANDA	GLAXOSMITHKLINE	001	NALLPEN	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	NAFCILLIN SODIUM	1986-12-19	Discontinued	No
062755	ANDA	GLAXOSMITHKLINE	002	NALLPEN	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	NAFCILLIN SODIUM	1986-12-19	Discontinued	No
062690	ANDA	GLAXOSMITHKLINE	001	TICAR	INJECTABLE;INJECTION	EQ 3GM BASE/VIAL	TICARCILLIN DISODIUM	1986-12-19	Discontinued	No
062691	ANDA	GLAXOSMITHKLINE	001	TIMENTIN	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL	CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM	1986-12-19	Discontinued	No
062727	ANDA	GLAXOSMITHKLINE	001	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	AMPICILLIN SODIUM	1986-12-19	Discontinued	No
062727	ANDA	GLAXOSMITHKLINE	002	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	AMPICILLIN SODIUM	1986-12-19	Discontinued	No
019112	NDA	GLAXOSMITHKLINE	001	VENTOLIN	TABLET;ORAL	EQ 2MG BASE	ALBUTEROL SULFATE	1986-07-10	Discontinued	No
019112	NDA	GLAXOSMITHKLINE	002	VENTOLIN	TABLET;ORAL	EQ 4MG BASE	ALBUTEROL SULFATE	1986-07-10	Discontinued	No
019435	NDA	GLAXOSMITHKLINE	001	NIX	LOTION;TOPICAL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PERMETHRIN	1986-03-31	Discontinued	No
018644	NDA	GLAXOSMITHKLINE	001	WELLBUTRIN	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BUPROPION HYDROCHLORIDE	1985-12-30	Discontinued	No
			002	WELLBUTRIN	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BUPROPION HYDROCHLORIDE	1985-12-30	Discontinued	No
			003	WELLBUTRIN	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BUPROPION HYDROCHLORIDE	1985-12-30	Discontinued	No
019434	NDA	GLAXOSMITHKLINE	001	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 6MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE HYDROCHLORIDE	1985-10-31	Discontinued	No
050590	NDA	GLAXOSMITHKLINE	001	TIMENTIN	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL	CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM	1985-04-01	Discontinued	No
			002	TIMENTIN	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL	CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM	1985-04-01	Discontinued	No
			003	TIMENTIN	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL	CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM	1985-04-01	Discontinued	No
018342	NDA	GLAXOSMITHKLINE	001	WELLCOVORIN	TABLET;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEUCOVORIN CALCIUM	1983-07-08	Discontinued	No
018342	NDA	GLAXOSMITHKLINE	002	WELLCOVORIN	TABLET;ORAL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LEUCOVORIN CALCIUM	1983-07-08	Discontinued	No
018603	NDA	GLAXOSMITHKLINE	001	ZOVIRAX	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ACYCLOVIR SODIUM	1982-10-22	Discontinued	No
			002	ZOVIRAX	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ACYCLOVIR SODIUM	1982-10-22	Discontinued	No
			003	ZOVIRAX	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ACYCLOVIR SODIUM	1982-10-22	Discontinued	No
018118	NDA	GLAXOSMITHKLINE LLC	001	LANOXICAPS	CAPSULE;ORAL	0.2MG	DIGOXIN	1982-07-26	Discontinued	No
			002	LANOXICAPS	CAPSULE;ORAL	0.05MG	DIGOXIN	1982-07-26	Discontinued	No
			003	LANOXICAPS	CAPSULE;ORAL	0.1MG	DIGOXIN	1982-07-26	Discontinued	No
			004	LANOXICAPS	CAPSULE;ORAL	0.15MG	DIGOXIN	1982-07-26	Discontinued	No
061334	ANDA	GLAXOSMITHKLINE	006	BACTOCILL	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1982-03-26	Discontinued	No
			007	BACTOCILL	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1982-03-26	Discontinued	No
			008	BACTOCILL	INJECTABLE;INJECTION	EQ 4GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1982-03-26	Discontinued	No
			009	BACTOCILL	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1982-03-26	Discontinued	No
			010	BACTOCILL	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OXACILLIN SODIUM	1982-03-26	Discontinued	No
018584	NDA	GLAXOSMITHKLINE	001	BECONASE	AEROSOL, METERED;NASAL	0.042MG/INH	BECLOMETHASONE DIPROPIONATE	1981-09-30	Discontinued	No
062321	ANDA	GLAXOSMITHKLINE	001	BACTOCILL	FOR SOLUTION;ORAL	EQ 250MG BASE/5ML	OXACILLIN SODIUM	1981-06-02	Discontinued	No
018473	NDA	GLAXOSMITHKLINE	001	VENTOLIN	AEROSOL, METERED;INHALATION	0.09MG/INH	ALBUTEROL	1981-05-01	Discontinued	No
062036	ANDA	GLAXOSMITHKLINE	001	AEROSPORIN	INJECTABLE;INJECTION	EQ 500,000 UNITS BASE/VIAL	POLYMYXIN B SULFATE	1980-11-13	Discontinued	No
062270	ANDA	GLAXOSMITHKLINE	001	BEEPEN-VK	FOR SOLUTION;ORAL	EQ 125MG BASE/5ML	PENICILLIN V POTASSIUM	1980-08-15	Discontinued	No
062270	ANDA	GLAXOSMITHKLINE	002	BEEPEN-VK	FOR SOLUTION;ORAL	EQ 250MG BASE/5ML	PENICILLIN V POTASSIUM	1980-08-15	Discontinued	No
062273	ANDA	GLAXOSMITHKLINE	001	BEEPEN-VK	TABLET;ORAL	EQ 250MG BASE	PENICILLIN V POTASSIUM	1980-08-12	Discontinued	No
062273	ANDA	GLAXOSMITHKLINE	002	BEEPEN-VK	TABLET;ORAL	EQ 500MG BASE	PENICILLIN V POTASSIUM	1980-08-12	Discontinued	No
018153	NDA	GLAXOSMITHKLINE	001	BECLOVENT	AEROSOL, METERED;INHALATION	0.042MG/INH	BECLOMETHASONE DIPROPIONATE	1980-06-24	Discontinued	No
062238	ANDA	GLAXOSMITHKLINE	001	DYCILL	CAPSULE;ORAL	EQ 250MG BASE	DICLOXACILLIN SODIUM	1979-12-31	Discontinued	No
062238	ANDA	GLAXOSMITHKLINE	002	DYCILL	CAPSULE;ORAL	EQ 500MG BASE	DICLOXACILLIN SODIUM	1979-12-31	Discontinued	No
062223	ANDA	GLAXOSMITHKLINE	001	TOTACILLIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	AMPICILLIN/AMPICILLIN TRIHYDRATE	1979-08-27	Discontinued	No
062223	ANDA	GLAXOSMITHKLINE	002	TOTACILLIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	AMPICILLIN/AMPICILLIN TRIHYDRATE	1979-08-27	Discontinued	No
062212	ANDA	GLAXOSMITHKLINE	001	TOTACILLIN	CAPSULE;ORAL	EQ 250MG BASE	AMPICILLIN/AMPICILLIN TRIHYDRATE	1979-08-02	Discontinued	No
062212	ANDA	GLAXOSMITHKLINE	002	TOTACILLIN	CAPSULE;ORAL	EQ 500MG BASE	AMPICILLIN/AMPICILLIN TRIHYDRATE	1979-08-02	Discontinued	No
017920	NDA	GLAXOSMITHKLINE	002	TAGAMET	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE	1977-08-16	Discontinued	No
			003	TAGAMET	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE	1977-08-16	Discontinued	No
			004	TAGAMET	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE	1977-08-16	Discontinued	No
			005	TAGAMET	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE	1977-08-16	Discontinued	No
017924	NDA	GLAXOSMITHKLINE	001	TAGAMET	SOLUTION;ORAL	EQ 300MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE HYDROCHLORIDE	1977-08-16	Discontinued	No
017939	NDA	GLAXOSMITHKLINE	002	TAGAMET	INJECTABLE;INJECTION	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CIMETIDINE HYDROCHLORIDE	1977-08-16	Discontinued	No
050497	NDA	GLAXOSMITHKLINE	001	TICAR	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	TICARCILLIN DISODIUM	1976-11-09	Discontinued	No
			002	TICAR	INJECTABLE;INJECTION	EQ 3GM BASE/VIAL	TICARCILLIN DISODIUM	1976-11-09	Discontinued	No
			003	TICAR	INJECTABLE;INJECTION	EQ 6GM BASE/VIAL	TICARCILLIN DISODIUM	1976-11-09	Discontinued	No
			004	TICAR	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	TICARCILLIN DISODIUM	1976-11-09	Discontinued	No
			005	TICAR	INJECTABLE;INJECTION	EQ 30GM BASE/VIAL	TICARCILLIN DISODIUM	1976-11-09	Discontinued	No
083902	ANDA	GLAXOSMITHKLINE	001	DEXEDRINE	ELIXIR;ORAL	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXTROAMPHETAMINE SULFATE	1976-02-26	Discontinued	No
084935	ANDA	GLAXOSMITHKLINE	001	DEXEDRINE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXTROAMPHETAMINE SULFATE	1976-02-26	Discontinued	No
061866	ANDA	GLAXOSMITHKLINE	001	ANSPOR	FOR SUSPENSION;ORAL	125MG/5ML	CEPHRADINE	1974-10-15	Discontinued	No
061866	ANDA	GLAXOSMITHKLINE	002	ANSPOR	FOR SUSPENSION;ORAL	250MG/5ML	CEPHRADINE	1974-10-15	Discontinued	No
061859	ANDA	GLAXOSMITHKLINE	001	ANSPOR	CAPSULE;ORAL	250MG	CEPHRADINE	1974-10-01	Discontinued	No
061859	ANDA	GLAXOSMITHKLINE	002	ANSPOR	CAPSULE;ORAL	500MG	CEPHRADINE	1974-10-01	Discontinued	No
061806	ANDA	GLAXOSMITHKLINE	001	CLOXAPEN	CAPSULE;ORAL	EQ 250MG BASE	CLOXACILLIN SODIUM	1974-09-17	Discontinued	No
061806	ANDA	GLAXOSMITHKLINE	002	CLOXAPEN	CAPSULE;ORAL	EQ 500MG BASE	CLOXACILLIN SODIUM	1974-09-17	Discontinued	No
050459	NDA	GLAXOSMITHKLINE	001	AMOXIL	CAPSULE;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMOXICILLIN	1974-01-18	Discontinued	No
050459	NDA	GLAXOSMITHKLINE	002	AMOXIL	CAPSULE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMOXICILLIN	1974-01-18	Discontinued	No
050460	NDA	GLAXOSMITHKLINE	001	AMOXIL	FOR SUSPENSION;ORAL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMOXICILLIN	1974-01-18	Discontinued	No
			002	AMOXIL	FOR SUSPENSION;ORAL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMOXICILLIN	1974-01-18	Discontinued	No
			005	AMOXIL	FOR SUSPENSION;ORAL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMOXICILLIN	1974-01-18	Discontinued	No
			006	LAROTID	FOR SUSPENSION;ORAL	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMOXICILLIN	1974-01-18	Discontinued	No
050461	NDA	GLAXOSMITHKLINE	001	ANCEF	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFAZOLIN SODIUM	1973-10-04	Discontinued	No
			002	ANCEF	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFAZOLIN SODIUM	1973-10-04	Discontinued	No
			003	ANCEF	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFAZOLIN SODIUM	1973-10-04	Discontinued	No
			004	ANCEF	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFAZOLIN SODIUM	1973-10-04	Discontinued	No
			005	ANCEF	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFAZOLIN SODIUM	1973-10-04	Discontinued	No
017352	NDA	GLAXOSMITHKLINE	001	FASTIN	CAPSULE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PHENTERMINE HYDROCHLORIDE	1973-08-14	Discontinued	No
061336	ANDA	GLAXOSMITHKLINE	001	BACTOCILL	CAPSULE;ORAL	EQ 250MG BASE	OXACILLIN SODIUM	1973-07-27	Discontinued	No
061336	ANDA	GLAXOSMITHKLINE	002	BACTOCILL	CAPSULE;ORAL	EQ 500MG BASE	OXACILLIN SODIUM	1973-07-27	Discontinued	No
060666	ANDA	GLAXOSMITHKLINE	001	TOTACILLIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	AMPICILLIN/AMPICILLIN TRIHYDRATE	1970-05-07	Discontinued	No
060666	ANDA	GLAXOSMITHKLINE	002	TOTACILLIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	AMPICILLIN/AMPICILLIN TRIHYDRATE	1970-05-07	Discontinued	No
011110	NDA	GLAXOSMITHKLINE	002	ACTIDIL	TABLET;ORAL	2.5MG	TRIPROLIDINE HYDROCHLORIDE		Discontinued	No
011496	NDA	GLAXOSMITHKLINE	002	ACTIDIL	SYRUP;ORAL	1.25MG/5ML	TRIPROLIDINE HYDROCHLORIDE		Discontinued	No
018996	NDA	GLAXOSMITHKLINE	001	ACTIFED	CAPSULE, EXTENDED RELEASE;ORAL	120MG;5MG	PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE		Discontinued	No
012575	NDA	GLAXOSMITHKLINE	003	ACTIFED W/ CODEINE	SYRUP;ORAL	10MG/5ML;30MG/5ML;1.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE		Discontinued	No
062241	ANDA	GLAXOSMITHKLINE	001	BACTOCILL	CAPSULE;ORAL	EQ 250MG BASE	OXACILLIN SODIUM		Discontinued	No
062241	ANDA	GLAXOSMITHKLINE	002	BACTOCILL	CAPSULE;ORAL	EQ 500MG BASE	OXACILLIN SODIUM		Discontinued	No
062233	ANDA	GLAXOSMITHKLINE	001	CLOXAPEN	CAPSULE;ORAL	EQ 250MG BASE	CLOXACILLIN SODIUM		Discontinued	No
062233	ANDA	GLAXOSMITHKLINE	002	CLOXAPEN	CAPSULE;ORAL	EQ 500MG BASE	CLOXACILLIN SODIUM		Discontinued	No
011276	NDA	GLAXOSMITHKLINE	001	COMPAZINE	CONCENTRATE;ORAL	EQ 10MG BASE/ML	PROCHLORPERAZINE EDISYLATE		Discontinued	No
009309	NDA	GLAXOSMITHKLINE	001	DIONOSIL AQUEOUS	SUSPENSION;INTRATRACHEAL	50%	PROPYLIODONE		Discontinued	No
009309	NDA	GLAXOSMITHKLINE	002	DIONOSIL OILY	SUSPENSION;INTRATRACHEAL	60%	PROPYLIODONE		Discontinued	No
060254	ANDA	GLAXOSMITHKLINE	002	DYCILL	CAPSULE;ORAL	EQ 250MG BASE	DICLOXACILLIN SODIUM		Discontinued	No
060254	ANDA	GLAXOSMITHKLINE	003	DYCILL	CAPSULE;ORAL	EQ 500MG BASE	DICLOXACILLIN SODIUM		Discontinued	No
083951	ANDA	GLAXOSMITHKLINE	001	EMPRACET W/ CODEINE PHOSPHATE #3	TABLET;ORAL	300MG;30MG	ACETAMINOPHEN; CODEINE PHOSPHATE		Discontinued	No
083951	ANDA	GLAXOSMITHKLINE	002	EMPRACET W/ CODEINE PHOSPHATE #4	TABLET;ORAL	300MG;60MG	ACETAMINOPHEN; CODEINE PHOSPHATE		Discontinued	No
011945	NDA	GLAXOSMITHKLINE	001	HISPRIL	CAPSULE, EXTENDED RELEASE;ORAL	5MG	DIPHENYLPYRALINE HYDROCHLORIDE		Discontinued	No
050579	NDA	GLAXOSMITHKLINE	001	MONOCID	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	CEFONICID SODIUM		Discontinued	No
			002	MONOCID	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	CEFONICID SODIUM		Discontinued	No
			003	MONOCID	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	CEFONICID SODIUM		Discontinued	No
			004	MONOCID	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	CEFONICID SODIUM		Discontinued	No
061999	ANDA	GLAXOSMITHKLINE	001	NALLPEN	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	NAFCILLIN SODIUM		Discontinued	No
			002	NALLPEN	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	NAFCILLIN SODIUM		Discontinued	No
			003	NALLPEN	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	NAFCILLIN SODIUM		Discontinued	No
			004	NALLPEN	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	NAFCILLIN SODIUM		Discontinued	No
050176	NDA	GLAXOSMITHKLINE	002	NEOSPORIN	CREAM;TOPICAL	EQ 3.5MG BASE/GM;10,000 UNITS/GM	NEOMYCIN SULFATE; POLYMYXIN B SULFATE		Discontinued	No
063322	ANDA	GLAXOSMITHKLINE	001	PENTACEF	INJECTABLE;INJECTION	1GM/VIAL	CEFTAZIDIME		Discontinued	No
063322	ANDA	GLAXOSMITHKLINE	002	PENTACEF	INJECTABLE;INJECTION	2GM/VIAL	CEFTAZIDIME		Discontinued	No
064006	ANDA	GLAXOSMITHKLINE	001	PENTACEF	INJECTABLE;INJECTION	1GM/VIAL	CEFTAZIDIME		Discontinued	No
064006	ANDA	GLAXOSMITHKLINE	002	PENTACEF	INJECTABLE;INJECTION	2GM/VIAL	CEFTAZIDIME		Discontinued	No
064008	ANDA	GLAXOSMITHKLINE	001	PENTACEF	INJECTABLE;INJECTION	6GM/VIAL	CEFTAZIDIME		Discontinued	No
064008	ANDA	GLAXOSMITHKLINE	002	PENTACEF	INJECTABLE;INJECTION	10GM/VIAL	CEFTAZIDIME		Discontinued	No
084060	ANDA	GLAXOSMITHKLINE	001	PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML	PHYTONADIONE		Discontinued	No
084060	ANDA	GLAXOSMITHKLINE	002	PHYTONADIONE	INJECTABLE;INJECTION	10MG/ML	PHYTONADIONE		Discontinued	No
050167	NDA	GLAXOSMITHKLINE	002	POLYSPORIN	AEROSOL;TOPICAL	10,000 UNITS/GM;2,000,000 UNITS/GM	BACITRACIN ZINC; POLYMYXIN B SULFATE		Discontinued	No
050298	NDA	GLAXOSMITHKLINE	001	PYOPEN	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	CARBENICILLIN DISODIUM		Discontinued	No
			002	PYOPEN	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	CARBENICILLIN DISODIUM		Discontinued	No
			003	PYOPEN	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL	CARBENICILLIN DISODIUM		Discontinued	No
			006	PYOPEN	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	CARBENICILLIN DISODIUM		Discontinued	No
			007	PYOPEN	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	CARBENICILLIN DISODIUM		Discontinued	No
062435	ANDA	GLAXOSMITHKLINE	001	SEFFIN	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	CEPHALOTHIN SODIUM		Discontinued	No
			002	SEFFIN	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	CEPHALOTHIN SODIUM		Discontinued	No
			003	SEFFIN	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	CEPHALOTHIN SODIUM		Discontinued	No
017941	NDA	GLAXOSMITHKLINE	002	SUDAFED 12 HOUR	CAPSULE, EXTENDED RELEASE;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PSEUDOEPHEDRINE HYDROCHLORIDE		Discontinued	No
006931	NDA	GLAXOSMITHKLINE	002	SYNCURINE	INJECTABLE;INJECTION	1MG/ML	DECAMETHONIUM BROMIDE		Discontinued	No
017369	NDA	GLAXOSMITHKLINE	001	TELDRIN	CAPSULE, EXTENDED RELEASE;ORAL	8MG	CHLORPHENIRAMINE MALEATE		Discontinued	No
017369	NDA	GLAXOSMITHKLINE	002	TELDRIN	CAPSULE, EXTENDED RELEASE;ORAL	12MG	CHLORPHENIRAMINE MALEATE		Discontinued	No
060060	ANDA	GLAXOSMITHKLINE	001	TOTACILLIN	CAPSULE;ORAL	EQ 250MG BASE	AMPICILLIN/AMPICILLIN TRIHYDRATE		Discontinued	No
060060	ANDA	GLAXOSMITHKLINE	002	TOTACILLIN	CAPSULE;ORAL	EQ 500MG BASE	AMPICILLIN/AMPICILLIN TRIHYDRATE		Discontinued	No
060677	ANDA	GLAXOSMITHKLINE	001	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 125MG BASE/VIAL	AMPICILLIN SODIUM		Discontinued	No
			002	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	AMPICILLIN SODIUM		Discontinued	No
			003	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	AMPICILLIN SODIUM		Discontinued	No
			004	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	AMPICILLIN SODIUM		Discontinued	No
			005	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	AMPICILLIN SODIUM		Discontinued	No
			006	TOTACILLIN-N	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	AMPICILLIN SODIUM		Discontinued	No
019174	NDA	GLAXOSMITHKLINE	001	TRANDATE HCT	TABLET;ORAL	25MG;100MG	HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE		Discontinued	No
			002	TRANDATE HCT	TABLET;ORAL	25MG;200MG	HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE		Discontinued	No
			003	TRANDATE HCT	TABLET;ORAL	25MG;300MG	HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE		Discontinued	No
			004	TRANDATE HCT	TABLET;ORAL	25MG;400MG	HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE		Discontinued	No
020559	NDA	GLAXOSMITHKLINE	001	TRITEC	TABLET;ORAL	400MG	RANITIDINE BISMUTH CITRATE		Discontinued	No
087439	ANDA	GLAXOSMITHKLINE	001	WELLCOVORIN	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	EQ 5MG BASE/ML (EQ 5MG BASE/ML)	LEUCOVORIN CALCIUM		Discontinued	No
087439	ANDA	GLAXOSMITHKLINE	002	WELLCOVORIN	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	LEUCOVORIN CALCIUM		Discontinued	No
089465	ANDA	GLAXOSMITHKLINE	001	WELLCOVORIN	INJECTABLE;INJECTION	EQ 50MG BASE/VIAL	LEUCOVORIN CALCIUM		Discontinued	No
089833	ANDA	GLAXOSMITHKLINE	001	WELLCOVORIN	INJECTABLE;INJECTION	EQ 25MG BASE/VIAL	LEUCOVORIN CALCIUM		Discontinued	No
089834	ANDA	GLAXOSMITHKLINE	001	WELLCOVORIN	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	LEUCOVORIN CALCIUM		Discontinued	No
015868	NDA	GLAXOSMITHKLINE	001	STOXIL	OINTMENT;OPHTHALMIC	0.5%	IDOXURIDINE	1967-09-02	Discontinued	No
016033	NDA	GLAXOSMITHKLINE	001	VONTROL	TABLET;ORAL	EQ 25MG BASE	DIPHENIDOL HYDROCHLORIDE	1967-04-05	Discontinued	No
016042	NDA	GLAXOSMITHKLINE LLC	002	DYAZIDE	CAPSULE;ORAL	25MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE; TRIAMTERENE	1965-12-02	Discontinued	No
016042	NDA	GLAXOSMITHKLINE LLC	003	DYAZIDE	CAPSULE;ORAL	25MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE; TRIAMTERENE	1965-12-02	Discontinued	No
013934	NDA	GLAXOSMITHKLINE	001	STOXIL	SOLUTION/DROPS;OPHTHALMIC	0.1%	IDOXURIDINE	1964-04-06	Discontinued	No
011552	NDA	GLAXOSMITHKLINE	001	STELAZINE	TABLET;ORAL	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRIFLUOPERAZINE HYDROCHLORIDE	1959-04-16	Discontinued	No
			002	STELAZINE	TABLET;ORAL	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRIFLUOPERAZINE HYDROCHLORIDE	1959-04-16	Discontinued	No
			003	STELAZINE	TABLET;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRIFLUOPERAZINE HYDROCHLORIDE	1959-04-16	Discontinued	No
			004	STELAZINE	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRIFLUOPERAZINE HYDROCHLORIDE	1959-04-16	Discontinued	No
			005	STELAZINE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRIFLUOPERAZINE HYDROCHLORIDE	1959-04-16	Discontinued	No
			006	STELAZINE	CONCENTRATE;ORAL	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRIFLUOPERAZINE HYDROCHLORIDE	1959-04-16	Discontinued	No
011127	NDA	GLAXOSMITHKLINE	001	COMPAZINE	SUPPOSITORY;RECTAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE	1959-01-26	Discontinued	No
			002	COMPAZINE	SUPPOSITORY;RECTAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE	1959-01-26	Discontinued	No
			003	COMPAZINE	SUPPOSITORY;RECTAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE	1959-01-26	Discontinued	No
011188	NDA	GLAXOSMITHKLINE	001	COMPAZINE	SYRUP;ORAL	EQ 5MG BASE/5ML	PROCHLORPERAZINE EDISYLATE	1957-12-10	Discontinued	No
009149	NDA	GLAXOSMITHKLINE	002	THORAZINE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			007	THORAZINE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			011	THORAZINE	INJECTABLE;INJECTION	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			013	THORAZINE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			018	THORAZINE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			020	THORAZINE	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			022	THORAZINE	SYRUP;ORAL	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			024	THORAZINE	SUPPOSITORY;RECTAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE	1957-11-20	Discontinued	No
			032	THORAZINE	CONCENTRATE;ORAL	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
			033	THORAZINE	SUPPOSITORY;RECTAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE	1957-11-20	Discontinued	No
			043	THORAZINE	CONCENTRATE;ORAL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CHLORPROMAZINE HYDROCHLORIDE	1957-11-20	Discontinued	No
010744	NDA	GLAXOSMITHKLINE	001	DARBID	TABLET;ORAL	EQ 5MG BASE	ISOPROPAMIDE IODIDE	1957-10-09	Discontinued	No
011120	NDA	GLAXOSMITHKLINE	016	THORAZINE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	CHLORPROMAZINE HYDROCHLORIDE	1957-09-18	Discontinued	No
			017	THORAZINE	CAPSULE, EXTENDED RELEASE;ORAL	75MG	CHLORPROMAZINE HYDROCHLORIDE	1957-09-18	Discontinued	No
			018	THORAZINE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	CHLORPROMAZINE HYDROCHLORIDE	1957-09-18	Discontinued	No
			019	THORAZINE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	CHLORPROMAZINE HYDROCHLORIDE	1957-09-18	Discontinued	No
			020	THORAZINE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	CHLORPROMAZINE HYDROCHLORIDE	1957-09-18	Discontinued	No
011000	NDA	GLAXOSMITHKLINE	001	COMPAZINE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 10MG BASE	PROCHLORPERAZINE MALEATE	1957-06-05	Discontinued	No
			002	COMPAZINE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE	PROCHLORPERAZINE MALEATE	1957-06-05	Discontinued	No
			003	COMPAZINE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 30MG BASE	PROCHLORPERAZINE MALEATE	1957-06-05	Discontinued	No
			004	COMPAZINE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 75MG BASE	PROCHLORPERAZINE MALEATE	1957-06-05	Discontinued	No
010742	NDA	GLAXOSMITHKLINE	002	COMPAZINE	INJECTABLE;INJECTION	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE EDISYLATE	1957-04-08	Discontinued	No
009102	NDA	GLAXOSMITHKLINE	001	ANTEPAR	SYRUP;ORAL	EQ 500MG BASE/5ML	PIPERAZINE CITRATE	1957-01-25	Discontinued	No
009102	NDA	GLAXOSMITHKLINE	003	ANTEPAR	TABLET;ORAL	EQ 500MG BASE	PIPERAZINE CITRATE	1957-01-25	Discontinued	No
010571	NDA	GLAXOSMITHKLINE	001	COMPAZINE	TABLET;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE MALEATE	1956-10-23	Discontinued	No
			002	COMPAZINE	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE MALEATE	1956-10-23	Discontinued	No
			003	COMPAZINE	TABLET;ORAL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROCHLORPERAZINE MALEATE	1956-10-23	Discontinued	No
009495	NDA	GLAXOSMITHKLINE	001	MAREZINE	INJECTABLE;INJECTION	50MG/ML	CYCLIZINE LACTATE	1954-09-24	Discontinued	No
006772	NDA	GLAXOSMITHKLINE	001	VASOXYL	INJECTABLE;INJECTION	20MG/ML	METHOXAMINE HYDROCHLORIDE	1949-03-28	Discontinued	No
006772	NDA	GLAXOSMITHKLINE	002	VASOXYL	INJECTABLE;INJECTION	10MG/ML	METHOXAMINE HYDROCHLORIDE	1949-03-28	Discontinued	No