FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
219943	NDA	ASTRAZENECA	001	KOSELUGO	GRANULE;ORAL	EQ 5MG BASE	SELUMETINIB SULFATE	2025-09-10	Prescription	No
			002	KOSELUGO	GRANULE;ORAL	EQ 7.5MG BASE	SELUMETINIB SULFATE	2025-09-10	Prescription	Yes
			003	KOSELUGO	CAPSULE; ORAL	10MG	SELUMETINIB	2025-09-10	Prescription	No
			004	KOSELUGO	CAPSULE; ORAL	25MG	SELUMETINIB	2025-09-10	Prescription	No
217388	NDA	ASTRAZENECA AB	001	WAINUA (AUTOINJECTOR)	SOLUTION;SUBCUTANEOUS	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	EPLONTERSEN SODIUM	2023-12-21	Prescription	Yes
218197	NDA	ASTRAZENECA	001	TRUQAP	TABLET;ORAL	160MG	CAPIVASERTIB	2023-11-16	Prescription	No
218197	NDA	ASTRAZENECA	002	TRUQAP	TABLET;ORAL	200MG	CAPIVASERTIB	2023-11-16	Prescription	Yes
761328	BLA	ASTRAZENECA AB	001	BEYFORTUS	INJECTABLE;INJECTION	50MG	NIRSEVIMAB-ALIP	2023-07-17	Prescription	No
761328	BLA	ASTRAZENECA AB	002	BEYFORTUS	INJECTABLE;INJECTION	100MG	NIRSEVIMAB-ALIP	2023-07-17	Prescription	No
216579	NDA	ASTRAZENECA	001	SYMBICORT AEROSPHERE	AEROSOL, METERED;INHALATION	0.16MG/INH;0.0048MG/INH	BUDESONIDE; FORMOTEROL FUMARATE	2023-04-28	Prescription	Yes
214070	NDA	ASTRAZENECA	001	AIRSUPRA	AEROSOL, METERED;INHALATION	EQ 0.09MG BASE/INH;0.08MG/INH	ALBUTEROL SULFATE; BUDESONIDE	2023-01-10	Prescription	Yes
761270	BLA	ASTRAZENECA AB	001	IMJUDO	INJECTABLE;INTRAVENOUS	25MG/1.25ML(20MG/ML)	TREMELIMUMAB-ACTL	2022-11-10	Prescription	No
761270	BLA	ASTRAZENECA AB	002	IMJUDO	INJECTABLE;INTRAVENOUS	300MG/15ML(20MG/ML)	TREMELIMUMAB-ACTL	2022-11-10	Prescription	No
761289	BLA	ASTRAZENECA AB	001	IMJUDO	INJECTABLE;INTRAVENOUS	25MG/1.25ML(20MG/ML)	TREMELIMUMAB-ACTL	2022-10-21	Prescription	No
761289	BLA	ASTRAZENECA AB	002	IMJUDO	INJECTABLE;INTRAVENOUS	300MG/15ML(20MG/ML)	TREMELIMUMAB-ACTL	2022-10-21	Prescription	No
216387	NDA	ASTRAZENECA	001	CALQUENCE	TABLET;ORAL	EQ 100MG BASE	ACALABRUTINIB MALEATE	2022-08-03	Prescription	Yes
761224	BLA	ASTRAZENECA AB	001	TEZSPIRE	SOLUTION;SUBCUTANEOUS	210MG/1.91ML(110MG/ML)	TEZEPELUMAB-EKKO	2021-12-17	Prescription	No
761123	BLA	ASTRAZENECA AB	001	SAPHNELO	INJECTABLE;INJECTION	300MG/2ML(150MG/ML)	ANIFROLUMAB-FNIA	2021-07-30	Prescription	No
212122	NDA	ASTRAZENECA AB	001	BREZTRI AEROSPHERE	AEROSOL, METERED;INHALATION	0.16MG/INH;0.0048MG/INH;0.009MG/INH	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	2020-07-23	Prescription	Yes
213756	NDA	ASTRAZENECA	001	KOSELUGO	CAPSULE;ORAL	EQ 10MG BASE	SELUMETINIB SULFATE	2020-04-10	Prescription	No
213756	NDA	ASTRAZENECA	002	KOSELUGO	CAPSULE;ORAL	EQ 25MG BASE	SELUMETINIB SULFATE	2020-04-10	Prescription	Yes
210874	NDA	ASTRAZENECA AB	001	QTERNMET XR	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM;EQ 2.5MG BASE	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2019-05-02	Discontinued	No
			002	QTERNMET XR	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM;EQ 2.5MG BASE	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2019-05-02	Discontinued	No
			003	QTERNMET XR	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM;EQ 5MG BASE	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2019-05-02	Discontinued	No
			004	QTERNMET XR	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM;EQ 5MG BASE	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2019-05-02	Discontinued	No
207078	NDA	ASTRAZENECA	001	LOKELMA	FOR SUSPENSION;ORAL	5GM/PACKET	SODIUM ZIRCONIUM CYCLOSILICATE	2018-05-18	Prescription	No
207078	NDA	ASTRAZENECA	002	LOKELMA	FOR SUSPENSION;ORAL	10GM/PACKET	SODIUM ZIRCONIUM CYCLOSILICATE	2018-05-18	Prescription	Yes
761070	BLA	ASTRAZENECA AB	001	FASENRA	INJECTABLE;INJECTION	30MG/ML	BENRALIZUMAB	2017-11-14	Prescription	No
210259	NDA	ASTRAZENECA	001	CALQUENCE	CAPSULE;ORAL	100MG	ACALABRUTINIB	2017-10-31	Prescription	Yes
209210	NDA	ASTRAZENECA AB	001	BYDUREON BCISE	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	2MG/0.85ML (2MG/0.85ML)	EXENATIDE SYNTHETIC	2017-10-20	Discontinued	No
208558	NDA	ASTRAZENECA	001	LYNPARZA	TABLET;ORAL	100MG	OLAPARIB	2017-08-17	Prescription	No
208558	NDA	ASTRAZENECA	002	LYNPARZA	TABLET;ORAL	150MG	OLAPARIB	2017-08-17	Prescription	Yes
761069	BLA	ASTRAZENECA UK LTD	001	IMFINZI	INJECTABLE;INJECTION	50MG/ML	DURVALUMAB	2017-05-01	Prescription	No
209091	NDA	ASTRAZENECA AB	001	QTERN	TABLET;ORAL	10MG;EQ 5MG BASE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	2017-02-27	Discontinued	No
209091	NDA	ASTRAZENECA AB	002	QTERN	TABLET;ORAL	5MG;EQ 5MG BASE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	2017-02-27	Discontinued	No
208294	NDA	ASTRAZENECA	001	BEVESPI AEROSPHERE	AEROSOL, METERED;INHALATION	0.0048MG/INH;0.0090MG/INH	FORMOTEROL FUMARATE; GLYCOPYRROLATE	2016-04-25	Prescription	Yes
207920	NDA	ASTRAZENECA LP	001	NEXIUM 24HR	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	ESOMEPRAZOLE MAGNESIUM	2015-11-23	Over-the-counter	Yes
208065	NDA	ASTRAZENECA	001	TAGRISSO	TABLET;ORAL	EQ 40MG BASE	OSIMERTINIB MESYLATE	2015-11-13	Prescription	No
208065	NDA	ASTRAZENECA	002	TAGRISSO	TABLET;ORAL	EQ 80MG BASE	OSIMERTINIB MESYLATE	2015-11-13	Prescription	Yes
206995	NDA	ASTRAZENECA	001	IRESSA	TABLET;ORAL	250MG	GEFITINIB	2015-07-13	Prescription	Yes
206162	NDA	ASTRAZENECA	001	LYNPARZA	CAPSULE;ORAL	50MG	OLAPARIB	2014-12-19	Discontinued	No
205649	NDA	ASTRAZENECA AB	001	XIGDUO XR	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-10-29	Prescription	No
			002	XIGDUO XR	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-10-29	Prescription	No
			003	XIGDUO XR	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-10-29	Prescription	No
			004	XIGDUO XR	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-10-29	Prescription	Yes
			005	XIGDUO XR	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2014-10-29	Prescription	No
205060	NDA	ASTRAZENECA	001	EPANOVA	CAPSULE;ORAL	1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS	OMEGA-3-CARBOXYLIC ACIDS	2014-05-05	Discontinued	No
204655	NDA	ASTRAZENECA LP	001	NEXIUM 24HR	CAPSULE, DELAYED RELEASE;ORAL	EQ 20MG BASE	ESOMEPRAZOLE MAGNESIUM	2014-03-28	Over-the-counter	Yes
202293	NDA	ASTRAZENECA AB	001	FARXIGA	TABLET;ORAL	5MG	DAPAGLIFLOZIN	2014-01-08	Prescription	No
202293	NDA	ASTRAZENECA AB	002	FARXIGA	TABLET;ORAL	10MG	DAPAGLIFLOZIN	2014-01-08	Prescription	Yes
022200	NDA	ASTRAZENECA AB	001	BYDUREON	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	2MG/VIAL	EXENATIDE SYNTHETIC	2012-01-27	Discontinued	No
022200	NDA	ASTRAZENECA AB	002	BYDUREON PEN	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	2MG	EXENATIDE SYNTHETIC	2012-01-27	Discontinued	No
022433	NDA	ASTRAZENECA	001	BRILINTA	TABLET;ORAL	90MG	TICAGRELOR	2011-07-20	Prescription	Yes
022433	NDA	ASTRAZENECA	002	BRILINTA	TABLET;ORAL	60MG	TICAGRELOR	2011-07-20	Prescription	No
022522	NDA	ASTRAZENECA	001	DALIRESP	TABLET;ORAL	500MCG	ROFLUMILAST	2011-02-28	Prescription	Yes
022522	NDA	ASTRAZENECA	002	DALIRESP	TABLET;ORAL	250MCG	ROFLUMILAST	2011-02-28	Prescription	No
200678	NDA	ASTRAZENECA AB	001	KOMBIGLYZE XR	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2010-11-05	Discontinued	No
			002	KOMBIGLYZE XR	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2010-11-05	Discontinued	No
			003	KOMBIGLYZE XR	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2010-11-05	Discontinued	No
022350	NDA	ASTRAZENECA AB	001	ONGLYZA	TABLET;ORAL	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SAXAGLIPTIN HYDROCHLORIDE	2009-07-31	Discontinued	No
022350	NDA	ASTRAZENECA AB	002	ONGLYZA	TABLET;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SAXAGLIPTIN HYDROCHLORIDE	2009-07-31	Discontinued	No
022310	NDA	ASTRAZENECA	001	CASODEX	TABLET; ORAL	50MG	BICALUTAMIDE	2008-12-19	Prescription	No
022214	NDA	ASTRAZENECA	001	ARIMIDEX	TABLET; ORAL	1MG	ANASTROZOLE	2008-12-05	Prescription	No
022101	NDA	ASTRAZENECA	001	NEXIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 10MG BASE/PACKET	ESOMEPRAZOLE MAGNESIUM	2008-02-27	Prescription	No
021957	NDA	ASTRAZENECA	001	NEXIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 20MG BASE/PACKET	ESOMEPRAZOLE MAGNESIUM	2006-10-20	Prescription	No
			002	NEXIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 40MG BASE/PACKET	ESOMEPRAZOLE MAGNESIUM	2006-10-20	Prescription	Yes
			003	NEXIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 2.5MG BASE/PACKET	ESOMEPRAZOLE MAGNESIUM	2006-10-20	Prescription	No
			004	NEXIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 5MG BASE/PACKET	ESOMEPRAZOLE MAGNESIUM	2006-10-20	Prescription	No
021929	NDA	ASTRAZENECA	001	SYMBICORT	AEROSOL, METERED;INHALATION	0.08MG/INH;0.0045MG/INH	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	2006-07-21	Prescription	Yes
021929	NDA	ASTRAZENECA	002	SYMBICORT	AEROSOL, METERED;INHALATION	0.16MG/INH;0.0045MG/INH	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	2006-07-21	Prescription	Yes
021773	NDA	ASTRAZENECA AB	001	BYETTA	INJECTABLE;SUBCUTANEOUS	300MCG/1.2ML (250MCG/ML)	EXENATIDE SYNTHETIC	2005-04-28	Discontinued	No
021773	NDA	ASTRAZENECA AB	002	BYETTA	INJECTABLE;SUBCUTANEOUS	600MCG/2.4ML (250MCG/ML)	EXENATIDE SYNTHETIC	2005-04-28	Discontinued	No
021689	NDA	ASTRAZENECA	001	NEXIUM IV	INJECTABLE;INTRAVENOUS	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ESOMEPRAZOLE SODIUM	2005-03-31	Discontinued	No
021689	NDA	ASTRAZENECA	002	NEXIUM IV	INJECTABLE;INTRAVENOUS	EQ 40MG BASE/VIAL	ESOMEPRAZOLE SODIUM	2005-03-31	Discontinued	No
021332	NDA	ASTRAZENECA AB	001	SYMLIN	INJECTABLE;SUBCUTANEOUS	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	PRAMLINTIDE ACETATE	2005-03-16	Discontinued	No
			002	SYMLIN	INJECTABLE;SUBCUTANEOUS	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	PRAMLINTIDE ACETATE	2005-03-16	Prescription	No
			003	SYMLIN	INJECTABLE;SUBCUTANEOUS	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	PRAMLINTIDE ACETATE	2005-03-16	Prescription	Yes
021366	NDA	ASTRAZENECA	002	CRESTOR	TABLET;ORAL	EQ 5MG BASE	ROSUVASTATIN CALCIUM	2003-08-12	Prescription	No
			003	CRESTOR	TABLET;ORAL	EQ 10MG BASE	ROSUVASTATIN CALCIUM	2003-08-12	Prescription	No
			004	CRESTOR	TABLET;ORAL	EQ 20MG BASE	ROSUVASTATIN CALCIUM	2003-08-12	Prescription	No
			005	CRESTOR	TABLET;ORAL	EQ 40MG BASE	ROSUVASTATIN CALCIUM	2003-08-12	Prescription	Yes
021229	NDA	ASTRAZENECA	001	PRILOSEC OTC	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	OMEPRAZOLE MAGNESIUM	2003-06-20	Over-the-counter	Yes
021399	NDA	ASTRAZENECA	001	IRESSA	TABLET;ORAL	250MG	GEFITINIB	2003-05-05	Discontinued	No
021344	NDA	ASTRAZENECA	001	FASLODEX	SOLUTION;INTRAMUSCULAR	250MG/5ML (50MG/ML)	FULVESTRANT	2002-04-25	Prescription	Yes
021344	NDA	ASTRAZENECA	002	FASLODEX	SOLUTION;INTRAMUSCULAR	125MG/2.5ML (50MG/ML)	FULVESTRANT	2002-04-25	Discontinued	No
021153	NDA	ASTRAZENECA	001	NEXIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	ESOMEPRAZOLE MAGNESIUM	2001-02-20	Prescription	No
021153	NDA	ASTRAZENECA	002	NEXIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG BASE	ESOMEPRAZOLE MAGNESIUM	2001-02-20	Prescription	Yes
021231	NDA	ASTRAZENECA	001	ZOMIG-ZMT	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	ZOLMITRIPTAN	2001-02-13	Discontinued	No
021231	NDA	ASTRAZENECA	002	ZOMIG-ZMT	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	ZOLMITRIPTAN	2001-02-13	Discontinued	No
020929	NDA	ASTRAZENECA	001	PULMICORT RESPULES	SUSPENSION;INHALATION	0.25MG/2ML	BUDESONIDE	2000-08-08	Prescription	No
			002	PULMICORT RESPULES	SUSPENSION;INHALATION	0.5MG/2ML	BUDESONIDE	2000-08-08	Prescription	No
			003	PULMICORT RESPULES	SUSPENSION;INHALATION	1MG/2ML	BUDESONIDE	2000-08-08	Prescription	Yes
020962	NDA	ASTRAZENECA	001	EMLA	DISC;TOPICAL	2.5%;2.5%	LIDOCAINE; PRILOCAINE	1998-02-04	Discontinued	No
020441	NDA	ASTRAZENECA	002	PULMICORT	POWDER, METERED;INHALATION	0.16MG/INH	BUDESONIDE	1997-06-24	Discontinued	No
020441	NDA	ASTRAZENECA	003	PULMICORT	POWDER, METERED;INHALATION	0.32MG/INH	BUDESONIDE	1997-06-24	Discontinued	No
020668	NDA	ASTRAZENECA	001	LEXXEL	TABLET, EXTENDED RELEASE;ORAL	5MG;5MG	ENALAPRIL MALEATE; FELODIPINE	1996-12-27	Discontinued	No
020668	NDA	ASTRAZENECA	002	LEXXEL	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG	ENALAPRIL MALEATE; FELODIPINE	1996-12-27	Discontinued	No
020233	NDA	ASTRAZENECA	001	RHINOCORT	AEROSOL, METERED;NASAL	0.032MG/INH	BUDESONIDE	1994-02-14	Discontinued	No
019834	NDA	ASTRAZENECA	001	PLENDIL	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FELODIPINE	1991-07-25	Discontinued	No
			002	PLENDIL	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FELODIPINE	1991-07-25	Discontinued	No
			004	PLENDIL	TABLET, EXTENDED RELEASE;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FELODIPINE	1991-07-25	Discontinued	No
089614	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.062%	ISOETHARINE HYDROCHLORIDE	1991-06-13	Discontinued	No
089615	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.125%	ISOETHARINE HYDROCHLORIDE	1991-06-13	Discontinued	No
089616	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.167%	ISOETHARINE HYDROCHLORIDE	1991-06-13	Discontinued	No
089617	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.2%	ISOETHARINE HYDROCHLORIDE	1991-06-13	Discontinued	No
089618	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.25%	ISOETHARINE HYDROCHLORIDE	1991-06-13	Discontinued	No
019810	NDA	ASTRAZENECA	001	PRILOSEC	CAPSULE, DELAYED REL PELLETS;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OMEPRAZOLE	1989-09-14	Discontinued	No
			002	PRILOSEC	CAPSULE, DELAYED REL PELLETS;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OMEPRAZOLE	1989-09-14	Discontinued	No
			003	PRILOSEC	CAPSULE, DELAYED REL PELLETS;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OMEPRAZOLE	1989-09-14	Discontinued	No
019058	NDA	ASTRAZENECA	001	TENORMIN	INJECTABLE;INJECTION	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ATENOLOL	1989-09-13	Discontinued	No
072018	ANDA	ASTRAZENECA	001	DROPERIDOL	INJECTABLE;INJECTION	2.5MG/ML	DROPERIDOL	1988-10-20	Discontinued	No
071018	ANDA	ASTRAZENECA	001	METAPROTERENOL SULFATE	SOLUTION;INHALATION	0.6%	METAPROTERENOL SULFATE	1988-07-27	Discontinued	No
071275	ANDA	ASTRAZENECA	001	METAPROTERENOL SULFATE	SOLUTION;INHALATION	0.4%	METAPROTERENOL SULFATE	1988-07-27	Discontinued	No
018257	NDA	ASTRAZENECA	001	TONOCARD	TABLET;ORAL	400MG	TOCAINIDE HYDROCHLORIDE	1984-11-09	Discontinued	No
018257	NDA	ASTRAZENECA	002	TONOCARD	TABLET;ORAL	600MG	TOCAINIDE HYDROCHLORIDE	1984-11-09	Discontinued	No
018555	NDA	ASTRAZENECA	001	YUTOPAR	TABLET;ORAL	10MG	RITODRINE HYDROCHLORIDE	1980-12-12	Discontinued	No
017970	NDA	ASTRAZENECA	001	NOLVADEX	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TAMOXIFEN CITRATE	1977-12-30	Discontinued	No
017970	NDA	ASTRAZENECA	002	NOLVADEX	TABLET;ORAL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TAMOXIFEN CITRATE	1977-12-30	Discontinued	No
017751	NDA	ASTRAZENECA	003	DURANEST	INJECTABLE;INJECTION	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETIDOCAINE HYDROCHLORIDE	1976-08-30	Discontinued	No
			004	DURANEST	INJECTABLE;INJECTION	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE	1976-08-30	Discontinued	No
			005	DURANEST	INJECTABLE;INJECTION	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ETIDOCAINE HYDROCHLORIDE	1976-08-30	Discontinued	No
			006	DURANEST	INJECTABLE;INJECTION	0.005MG/ML;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	1976-08-30	Discontinued	No
			007	DURANEST	INJECTABLE;INJECTION	0.005MG/ML;1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	1976-08-30	Discontinued	No
016776	NDA	ASTRAZENECA	002	SORBITRATE	TABLET, CHEWABLE;ORAL	5MG	ISOSORBIDE DINITRATE	1970-12-07	Discontinued	No
016776	NDA	ASTRAZENECA	003	SORBITRATE	TABLET, CHEWABLE;ORAL	10MG	ISOSORBIDE DINITRATE	1970-12-07	Discontinued	No
083080	ANDA	ASTRAZENECA	001	AQUASOL A	CAPSULE;ORAL	50,000USP UNITS	VITAMIN A		Discontinued	No
083080	ANDA	ASTRAZENECA	002	AQUASOL A	CAPSULE;ORAL	25,000USP UNITS	VITAMIN A		Discontinued	No
071151	ANDA	ASTRAZENECA	001	BRETYLIUM TOSYLATE	INJECTABLE;INJECTION	50MG/ML	BRETYLIUM TOSYLATE		Discontinued	No
071152	ANDA	ASTRAZENECA	001	BRETYLIUM TOSYLATE	INJECTABLE;INJECTION	50MG/ML	BRETYLIUM TOSYLATE		Discontinued	No
071153	ANDA	ASTRAZENECA	001	BRETYLIUM TOSYLATE	INJECTABLE;INJECTION	50MG/ML	BRETYLIUM TOSYLATE		Discontinued	No
019082	NDA	ASTRAZENECA	001	DALGAN	INJECTABLE;INJECTION	5MG/ML	DEZOCINE		Discontinued	No
			002	DALGAN	INJECTABLE;INJECTION	10MG/ML	DEZOCINE		Discontinued	No
			003	DALGAN	INJECTABLE;INJECTION	15MG/ML	DEZOCINE		Discontinued	No
009925	NDA	ASTRAZENECA	001	DYCLONE	SOLUTION;TOPICAL	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DYCLONINE HYDROCHLORIDE		Discontinued	No
009925	NDA	ASTRAZENECA	002	DYCLONE	SOLUTION;TOPICAL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DYCLONINE HYDROCHLORIDE		Discontinued	No
072026	ANDA	ASTRAZENECA	001	FENTANYL CITRATE AND DROPERIDOL	INJECTABLE;INJECTION	2.5MG/ML;EQ 0.05MG BASE/ML	DROPERIDOL; FENTANYL CITRATE		Discontinued	No
072027	ANDA	ASTRAZENECA	001	FENTANYL CITRATE AND DROPERIDOL	INJECTABLE;INJECTION	2.5MG/ML;EQ 0.05MG BASE/ML	DROPERIDOL; FENTANYL CITRATE		Discontinued	No
072028	ANDA	ASTRAZENECA	001	FENTANYL CITRATE AND DROPERIDOL	INJECTABLE;INJECTION	2.5MG/ML;EQ 0.05MG BASE/ML	DROPERIDOL; FENTANYL CITRATE		Discontinued	No
070014	ANDA	ASTRAZENECA	001	FUROSEMIDE	INJECTABLE;INJECTION	10MG/ML	FUROSEMIDE		Discontinued	No
087937	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.062%	ISOETHARINE HYDROCHLORIDE		Discontinued	No
087938	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.125%	ISOETHARINE HYDROCHLORIDE		Discontinued	No
088470	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.167%	ISOETHARINE HYDROCHLORIDE		Discontinued	No
088471	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.2%	ISOETHARINE HYDROCHLORIDE		Discontinued	No
088472	ANDA	ASTRAZENECA	001	ISOETHARINE HYDROCHLORIDE	SOLUTION;INHALATION	0.25%	ISOETHARINE HYDROCHLORIDE		Discontinued	No
072081	ANDA	ASTRAZENECA	001	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/ML	NALOXONE HYDROCHLORIDE		Discontinued	No
016191	NDA	ASTRAZENECA	001	SORBITRATE	TABLET;SUBLINGUAL	5MG	ISOSORBIDE DINITRATE		Discontinued	No
016191	NDA	ASTRAZENECA	002	SORBITRATE	TABLET;SUBLINGUAL	2.5MG	ISOSORBIDE DINITRATE		Discontinued	No
086405	ANDA	ASTRAZENECA	002	SORBITRATE	TABLET;ORAL	20MG	ISOSORBIDE DINITRATE		Discontinued	No
088124	ANDA	ASTRAZENECA	001	SORBITRATE	TABLET;ORAL	30MG	ISOSORBIDE DINITRATE		Discontinued	No
088125	ANDA	ASTRAZENECA	001	SORBITRATE	TABLET;ORAL	40MG	ISOSORBIDE DINITRATE		Discontinued	No
010418	NDA	ASTRAZENECA	005	XYLOCAINE	INJECTABLE;INJECTION	1%	LIDOCAINE HYDROCHLORIDE		Discontinued	No
			007	XYLOCAINE	INJECTABLE;INJECTION	2%	LIDOCAINE HYDROCHLORIDE		Discontinued	No
			009	XYLOCAINE	INJECTABLE;INJECTION	1.5%	LIDOCAINE HYDROCHLORIDE		Discontinued	No
			006	XYLOCAINE W/ EPINEPHRINE	INJECTABLE;INJECTION	0.005MG/ML;1%	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE		Discontinued	No
			008	XYLOCAINE W/ EPINEPHRINE	INJECTABLE;INJECTION	0.005MG/ML;2%	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE		Discontinued	No
			010	XYLOCAINE W/ EPINEPHRINE	INJECTABLE;INJECTION	0.005MG/ML;1.5%	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE		Discontinued	No
018580	NDA	ASTRAZENECA	001	YUTOPAR	INJECTABLE;INJECTION	10MG/ML	RITODRINE HYDROCHLORIDE		Discontinued	No
018580	NDA	ASTRAZENECA	002	YUTOPAR	INJECTABLE;INJECTION	15MG/ML	RITODRINE HYDROCHLORIDE		Discontinued	No
016192	NDA	ASTRAZENECA	001	SORBITRATE	TABLET;ORAL	5MG	ISOSORBIDE DINITRATE	1968-01-16	Discontinued	No
016192	NDA	ASTRAZENECA	002	SORBITRATE	TABLET;ORAL	10MG	ISOSORBIDE DINITRATE	1968-01-16	Discontinued	No
014763	NDA	ASTRAZENECA	003	CITANEST	INJECTABLE;INJECTION	3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PRILOCAINE HYDROCHLORIDE	1965-11-18	Discontinued	No
			004	CITANEST	INJECTABLE;INJECTION	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PRILOCAINE HYDROCHLORIDE	1965-11-18	Discontinued	No
			005	CITANEST	INJECTABLE;INJECTION	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PRILOCAINE HYDROCHLORIDE	1965-11-18	Discontinued	No
			008	CITANEST FORTE	INJECTABLE;INJECTION	0.005MG/ML;4%	EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE	1965-11-18	Discontinued	No
			007	CITANEST PLAIN	INJECTABLE;INJECTION	4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PRILOCAINE HYDROCHLORIDE	1965-11-18	Discontinued	No
014394	NDA	ASTRAZENECA	001	XYLOCAINE	AEROSOL;ORAL	10%	LIDOCAINE	1965-04-20	Discontinued	No
014127	NDA	ASTRAZENECA	001	XYLOCAINE	SOLUTION;TOPICAL	5%	LIDOCAINE	1964-03-11	Discontinued	No
013077	NDA	ASTRAZENECA	001	XYLOCAINE	SUPPOSITORY;RECTAL	100MG	LIDOCAINE	1964-03-06	Discontinued	No
012704	NDA	ASTRAZENECA	001	ELAVIL	INJECTABLE;INJECTION	10MG/ML	AMITRIPTYLINE HYDROCHLORIDE	1961-04-11	Discontinued	No
012703	NDA	ASTRAZENECA	001	ELAVIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE	1961-04-07	Discontinued	No
			003	ELAVIL	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE	1961-04-07	Discontinued	No
			004	ELAVIL	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE	1961-04-07	Discontinued	No
			005	ELAVIL	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE	1961-04-07	Discontinued	No
			006	ELAVIL	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE	1961-04-07	Discontinued	No
			007	ELAVIL	TABLET;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE	1961-04-07	Discontinued	No
010496	NDA	ASTRAZENECA	002	XYLOCAINE 5% W/ GLUCOSE 7.5%	INJECTABLE;SPINAL	5%	LIDOCAINE HYDROCHLORIDE	1958-03-11	Discontinued	No
008048	NDA	ASTRAZENECA	001	XYLOCAINE	OINTMENT;TOPICAL	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LIDOCAINE	1951-05-17	Discontinued	No