FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
091222	ANDA	HLTHCARE	001	PREGABALIN	CAPSULE;ORAL	25MG	PREGABALIN	2025-02-21	Prescription	No
			002	PREGABALIN	CAPSULE;ORAL	50MG	PREGABALIN	2025-02-21	Prescription	No
			003	PREGABALIN	CAPSULE;ORAL	75MG	PREGABALIN	2025-02-21	Prescription	No
			004	PREGABALIN	CAPSULE;ORAL	100MG	PREGABALIN	2025-02-21	Prescription	No
			005	PREGABALIN	CAPSULE;ORAL	150MG	PREGABALIN	2025-02-21	Prescription	No
			006	PREGABALIN	CAPSULE;ORAL	200MG	PREGABALIN	2025-02-21	Prescription	No
			007	PREGABALIN	CAPSULE;ORAL	225MG	PREGABALIN	2025-02-21	Prescription	No
			008	PREGABALIN	CAPSULE;ORAL	300MG	PREGABALIN	2025-02-21	Prescription	No
204962	ANDA	PHARM ASSOC	001	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 30MG BASE/5ML	PREDNISOLONE SODIUM PHOSPHATE	2020-03-11	Discontinued	No
210766	ANDA	PHARM ASSOC	001	POTASSIUM CHLORIDE	SOLUTION;ORAL	20MEQ/15ML	POTASSIUM CHLORIDE	2019-03-29	Prescription	No
210766	ANDA	PHARM ASSOC	002	POTASSIUM CHLORIDE	SOLUTION;ORAL	40MEQ/15ML	POTASSIUM CHLORIDE	2019-03-29	Prescription	No
206914	ANDA	PHARM ASSOC	001	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	OXYCODONE HYDROCHLORIDE	2019-02-01	Prescription	No
209501	NDA	UPJOHN	001	LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	82.5MG	PREGABALIN	2017-10-11	Prescription	No
			002	LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	165MG	PREGABALIN	2017-10-11	Prescription	No
			003	LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	330MG	PREGABALIN	2017-10-11	Prescription	Yes
206822	ANDA	PHARM ASSOC	001	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	100MG/5ML	OXYCODONE HYDROCHLORIDE	2017-08-15	Discontinued	No
203291	ANDA	HLTHCARE	001	DROSPIRENONE AND ETHINYL ESTRADIOL	TABLET;ORAL	3MG;0.02MG	DROSPIRENONE; ETHINYL ESTRADIOL	2017-07-18	Prescription	No
203550	ANDA	HLTHCARE	001	METHOCARBAMOL	TABLET;ORAL	500MG	METHOCARBAMOL	2017-02-08	Prescription	No
203550	ANDA	HLTHCARE	002	METHOCARBAMOL	TABLET;ORAL	750MG	METHOCARBAMOL	2017-02-08	Prescription	No
206344	ANDA	PHARM ASSOC	001	THEOPHYLLINE	SOLUTION, ELIXIR;ORAL	80MG/15ML	THEOPHYLLINE	2016-12-16	Prescription	No
206573	ANDA	PHARM ASSOC	001	MORPHINE SULFATE	SOLUTION;ORAL	100MG/5ML	MORPHINE SULFATE	2016-11-14	Prescription	No
206573	ANDA	PHARM ASSOC	002	MORPHINE SULFATE	SOLUTION;ORAL	10MG/5ML	MORPHINE SULFATE	2016-11-14	Prescription	No
203621	ANDA	PHARM ASSOC	001	NYSTATIN	SUSPENSION;ORAL	100,000 UNITS/ML	NYSTATIN	2016-01-07	Prescription	No
201157	ANDA	PHARM ASSOC	001	LEVETIRACETAM	SOLUTION;ORAL	100MG/ML	LEVETIRACETAM	2015-06-04	Prescription	No
202940	ANDA	PHARM ASSOC	001	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	SYRUP;ORAL	2MG/5ML;10MG/5ML;30MG/5ML	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2014-07-21	Prescription	No
040838	ANDA	PHARM ASSOC	001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	SOLUTION;ORAL	325MG/15ML;7.5MG/15ML	ACETAMINOPHEN; HYDROCODONE BITARTRATE	2013-05-10	Prescription	No
091295	ANDA	PHARM ASSOC	001	CYPROHEPTADINE HYDROCHLORIDE	SYRUP;ORAL	2MG/5ML	CYPROHEPTADINE HYDROCHLORIDE	2013-03-28	Discontinued	No
091588	ANDA	PHARMACO	001	MONTELUKAST SODIUM	TABLET, CHEWABLE;ORAL	EQ 4MG BASE	MONTELUKAST SODIUM	2012-08-03	Discontinued	No
091588	ANDA	PHARMACO	002	MONTELUKAST SODIUM	TABLET, CHEWABLE;ORAL	EQ 5MG BASE	MONTELUKAST SODIUM	2012-08-03	Discontinued	No
200146	ANDA	HLTHCARE	001	DOXORUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	2MG/ML	DOXORUBICIN HYDROCHLORIDE	2012-07-18	Discontinued	No
090260	ANDA	PHARM ASSOC	001	LORAZEPAM	CONCENTRATE;ORAL	2MG/ML	LORAZEPAM	2010-06-15	Prescription	No
022488	NDA	UPJOHN	001	LYRICA	SOLUTION;ORAL	20MG/ML	PREGABALIN	2010-01-04	Prescription	Yes
077719	ANDA	PHARM ASSOC	001	RISPERIDONE	SOLUTION;ORAL	1MG/ML	RISPERIDONE	2009-07-29	Discontinued	No
078412	ANDA	PHARM ASSOC	001	CETIRIZINE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	CETIRIZINE HYDROCHLORIDE	2008-06-18	Prescription	No
078988	ANDA	PHARM ASSOC	001	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 20MG BASE/5ML	PREDNISOLONE SODIUM PHOSPHATE	2008-06-09	Prescription	Yes
090188	ANDA	PHARM ASSOC	002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	SOLUTION;ORAL	5MG/5ML	CETIRIZINE HYDROCHLORIDE	2008-04-22	Discontinued	No
090188	ANDA	PHARM ASSOC	001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	SOLUTION;ORAL	5MG/5ML	CETIRIZINE HYDROCHLORIDE	2008-04-22	Discontinued	No
040834	ANDA	PHARM ASSOC	001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	SOLUTION;ORAL	325MG/15ML;10MG/15ML	ACETAMINOPHEN; HYDROCODONE BITARTRATE	2008-04-18	Prescription	Yes
078465	ANDA	PHARM ASSOC	001	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 10MG BASE/5ML	PREDNISOLONE SODIUM PHOSPHATE	2008-03-07	Prescription	Yes
022124	NDA	NYCOMED US INC	001	OMNARIS	SPRAY; NASAL	50MCG	CICLESONIDE	2007-11-21	Prescription	No
077405	ANDA	PHARM ASSOC	001	RANITIDINE HYDROCHLORIDE	SYRUP;ORAL	EQ 15MG BASE/ML	RANITIDINE HYDROCHLORIDE	2007-09-21	Discontinued	No
078127	ANDA	PHARM ASSOC	001	ONDANSETRON HYDROCHLORIDE	SOLUTION;ORAL	EQ 4MG BASE/5ML	ONDANSETRON HYDROCHLORIDE	2007-06-25	Discontinued	No
040643	ANDA	PHARM ASSOC	001	PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	6.25MG/5ML	PROMETHAZINE HYDROCHLORIDE	2006-04-26	Prescription	No
040650	ANDA	PHARM ASSOC	001	PROMETHAZINE WITH CODEINE	SYRUP;ORAL	10MG/5ML;6.25MG/5ML	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	2006-01-31	Discontinued	No
021858	NDA	ROCHE	001	BONIVA	INJECTABLE;INTRAVENOUS	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	IBANDRONATE SODIUM	2006-01-06	Discontinued	No
077601	ANDA	PHARM ASSOC	001	CITALOPRAM HYDROBROMIDE	SOLUTION;ORAL	EQ 10MG BASE/5ML	CITALOPRAM HYDROBROMIDE	2005-11-15	Discontinued	No
077115	ANDA	PHARM ASSOC	001	MIDAZOLAM HYDROCHLORIDE	SYRUP;ORAL	EQ 2MG BASE/ML	MIDAZOLAM HYDROCHLORIDE	2005-09-09	Discontinued	No
040570	ANDA	PHARM ASSOC	001	PREDNISOLONE	SYRUP;ORAL	5MG/5ML	PREDNISOLONE	2005-08-25	Discontinued	No
040571	ANDA	PHARM ASSOC	001	PREDNISOLONE	SOLUTION;ORAL	15MG/5ML	PREDNISOLONE	2005-08-25	Prescription	No
076913	ANDA	PHARM ASSOC	001	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 15MG BASE/5ML	PREDNISOLONE SODIUM PHOSPHATE	2005-04-25	Prescription	Yes
065167	ANDA	PHARM ASSOC	001	CYCLOSPORINE	SOLUTION;ORAL	100MG/ML	CYCLOSPORINE	2005-01-05	Discontinued	No
021446	NDA	UPJOHN	001	LYRICA	CAPSULE;ORAL	25MG	PREGABALIN	2004-12-30	Prescription	No
			002	LYRICA	CAPSULE;ORAL	50MG	PREGABALIN	2004-12-30	Prescription	No
			003	LYRICA	CAPSULE;ORAL	75MG	PREGABALIN	2004-12-30	Prescription	No
			004	LYRICA	CAPSULE;ORAL	100MG	PREGABALIN	2004-12-30	Prescription	No
			005	LYRICA	CAPSULE;ORAL	150MG	PREGABALIN	2004-12-30	Prescription	No
			006	LYRICA	CAPSULE;ORAL	200MG	PREGABALIN	2004-12-30	Prescription	No
			007	LYRICA	CAPSULE;ORAL	225MG	PREGABALIN	2004-12-30	Prescription	No
			008	LYRICA	CAPSULE;ORAL	300MG	PREGABALIN	2004-12-30	Prescription	Yes
075565	ANDA	PHARM ASSOC	001	LORATADINE	SYRUP;ORAL	1MG/ML	LORATADINE	2004-10-05	Discontinued	No
075565	ANDA	PHARM ASSOC	002	LORATADINE	SYRUP; ORAL	5MG/5ML	LORATADINE	2004-10-05	Over-the-counter	No
075924	ANDA	PHARM ASSOC	001	DOXEPIN HYDROCHLORIDE	CONCENTRATE;ORAL	EQ 10MG BASE/ML	DOXEPIN HYDROCHLORIDE	2004-01-15	Discontinued	No
021481	NDA	ROCHE	001	FUZEON	INJECTABLE;SUBCUTANEOUS	90MG/VIAL	ENFUVIRTIDE	2003-03-13	Discontinued	No
040399	ANDA	PHARM ASSOC	001	PREDNISOLONE	SOLUTION;ORAL	15MG/5ML	PREDNISOLONE	2003-03-05	Discontinued	No
021434	NDA	UPJOHN	001	XANAX XR	TABLET, EXTENDED RELEASE;ORAL	0.5MG	ALPRAZOLAM	2003-01-17	Prescription	No
			002	XANAX XR	TABLET, EXTENDED RELEASE;ORAL	1MG	ALPRAZOLAM	2003-01-17	Prescription	No
			003	XANAX XR	TABLET, EXTENDED RELEASE;ORAL	2MG	ALPRAZOLAM	2003-01-17	Prescription	No
			004	XANAX XR	TABLET, EXTENDED RELEASE;ORAL	3MG	ALPRAZOLAM	2003-01-17	Prescription	Yes
021016	NDA	UPJOHN	001	RELPAX	TABLET;ORAL	EQ 20MG BASE	ELETRIPTAN HYDROBROMIDE	2002-12-26	Prescription	No
021016	NDA	UPJOHN	002	RELPAX	TABLET;ORAL	EQ 40MG BASE	ELETRIPTAN HYDROBROMIDE	2002-12-26	Prescription	Yes
076123	ANDA	PHARM ASSOC	001	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 5MG BASE/5ML	PREDNISOLONE SODIUM PHOSPHATE	2002-12-23	Discontinued	No
021511	NDA	ROCHE	001	COPEGUS	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIBAVIRIN	2002-12-03	Discontinued	No
021511	NDA	ROCHE	002	COPEGUS	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIBAVIRIN	2002-12-03	Discontinued	No
021437	NDA	UPJOHN	001	INSPRA	TABLET;ORAL	25MG	EPLERENONE	2002-09-27	Prescription	No
			002	INSPRA	TABLET;ORAL	50MG	EPLERENONE	2002-09-27	Prescription	Yes
			003	INSPRA	TABLET;ORAL	100MG	EPLERENONE	2002-09-27	Discontinued	No
076015	ANDA	PHARM ASSOC	001	FLUOXETINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 20MG BASE/5ML	FLUOXETINE HYDROCHLORIDE	2002-01-30	Prescription	Yes
021238	NDA	ROCHE	001	KYTRIL	SOLUTION;ORAL	EQ 2MG BASE/10ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	2001-06-27	Discontinued	No
040360	ANDA	PHARM ASSOC	001	PERPHENAZINE	CONCENTRATE;ORAL	16MG/5ML	PERPHENAZINE	2001-05-25	Discontinued	No
021228	NDA	UPJOHN	001	DETROL LA	CAPSULE, EXTENDED RELEASE;ORAL	2MG	TOLTERODINE TARTRATE	2000-12-22	Prescription	No
021228	NDA	UPJOHN	002	DETROL LA	CAPSULE, EXTENDED RELEASE;ORAL	4MG	TOLTERODINE TARTRATE	2000-12-22	Prescription	Yes
075379	ANDA	PHARM ASSOC	001	VALPROIC ACID	SYRUP;ORAL	250MG/5ML	VALPROIC ACID	2000-12-15	Prescription	Yes
021246	NDA	ROCHE	001	TAMIFLU	FOR SUSPENSION;ORAL	EQ 12MG BASE/ML	OSELTAMIVIR PHOSPHATE	2000-12-14	Discontinued	No
021246	NDA	ROCHE	002	TAMIFLU	FOR SUSPENSION;ORAL	EQ 6MG BASE/ML	OSELTAMIVIR PHOSPHATE	2000-12-14	Prescription	Yes
040253	ANDA	PHARM ASSOC	001	ETHOSUXIMIDE	SYRUP;ORAL	250MG/5ML	ETHOSUXIMIDE	2000-11-22	Prescription	No
075606	ANDA	PHARM ASSOC	001	NORTRIPTYLINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 10MG BASE/5ML	NORTRIPTYLINE HYDROCHLORIDE	2000-08-23	Prescription	Yes
075560	ANDA	PHARM ASSOC	001	CIMETIDINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 300MG BASE/5ML	CIMETIDINE HYDROCHLORIDE	2000-03-15	Discontinued	No
040231	ANDA	PHARM ASSOC	001	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	30MG/ML	CHLORPROMAZINE HYDROCHLORIDE	1999-12-30	Discontinued	No
021087	NDA	ROCHE	001	TAMIFLU	CAPSULE;ORAL	EQ 75MG BASE	OSELTAMIVIR PHOSPHATE	1999-10-27	Prescription	Yes
			002	TAMIFLU	CAPSULE;ORAL	EQ 45MG BASE	OSELTAMIVIR PHOSPHATE	1999-10-27	Prescription	No
			003	TAMIFLU	CAPSULE;ORAL	EQ 30MG BASE	OSELTAMIVIR PHOSPHATE	1999-10-27	Prescription	No
040224	ANDA	PHARM ASSOC	001	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	100MG/ML	CHLORPROMAZINE HYDROCHLORIDE	1999-01-26	Discontinued	No
020998	NDA	UPJOHN	001	CELEBREX	CAPSULE;ORAL	100MG	CELECOXIB	1998-12-31	Prescription	No
			002	CELEBREX	CAPSULE;ORAL	200MG	CELECOXIB	1998-12-31	Prescription	No
			003	CELEBREX	CAPSULE;ORAL	400MG	CELECOXIB	1998-12-31	Prescription	Yes
			004	CELEBREX	CAPSULE;ORAL	50MG	CELECOXIB	1998-12-31	Prescription	No
075137	ANDA	PHARM ASSOC	001	OXYBUTYNIN CHLORIDE	SYRUP;ORAL	5MG/5ML	OXYBUTYNIN CHLORIDE	1998-12-18	Discontinued	No
020942	NDA	ROCHE	001	VERSED	SYRUP;ORAL	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MIDAZOLAM HYDROCHLORIDE	1998-10-15	Discontinued	No
040213	ANDA	PHARM ASSOC	001	THIORIDAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	100MG/ML	THIORIDAZINE HYDROCHLORIDE	1998-05-29	Discontinued	No
020771	NDA	UPJOHN	001	DETROL	TABLET;ORAL	1MG	TOLTERODINE TARTRATE	1998-03-25	Prescription	No
020771	NDA	UPJOHN	002	DETROL	TABLET;ORAL	2MG	TOLTERODINE TARTRATE	1998-03-25	Prescription	Yes
040182	ANDA	PHARM ASSOC	001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	SOLUTION;ORAL	500MG/15ML;7.5MG/15ML	ACETAMINOPHEN; HYDROCODONE BITARTRATE	1998-03-13	Discontinued	No
020813	NDA	ROCHE	001	KLONOPIN RAPIDLY DISINTEGRATING	TABLET, ORALLY DISINTEGRATING;ORAL	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLONAZEPAM	1997-12-23	Discontinued	No
			002	KLONOPIN RAPIDLY DISINTEGRATING	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLONAZEPAM	1997-12-23	Discontinued	No
			003	KLONOPIN RAPIDLY DISINTEGRATING	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLONAZEPAM	1997-12-23	Discontinued	No
			004	KLONOPIN RAPIDLY DISINTEGRATING	TABLET, ORALLY DISINTEGRATING;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLONAZEPAM	1997-12-23	Discontinued	No
			005	KLONOPIN RAPIDLY DISINTEGRATING	TABLET, ORALLY DISINTEGRATING;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CLONAZEPAM	1997-12-23	Discontinued	No
020699	NDA	UPJOHN	001	EFFEXOR XR	CAPSULE, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	VENLAFAXINE HYDROCHLORIDE	1997-10-20	Prescription	No
			002	EFFEXOR XR	CAPSULE, EXTENDED RELEASE;ORAL	EQ 75MG BASE	VENLAFAXINE HYDROCHLORIDE	1997-10-20	Prescription	No
			003	EFFEXOR XR	CAPSULE, EXTENDED RELEASE;ORAL	EQ 100MG BASE	VENLAFAXINE HYDROCHLORIDE	1997-10-20	Discontinued	No
			004	EFFEXOR XR	CAPSULE, EXTENDED RELEASE;ORAL	EQ 150MG BASE	VENLAFAXINE HYDROCHLORIDE	1997-10-20	Prescription	Yes
074997	ANDA	PHARM ASSOC	001	OXYBUTYNIN CHLORIDE	SYRUP;ORAL	5MG/5ML	OXYBUTYNIN CHLORIDE	1997-10-15	Discontinued	No
040187	ANDA	PHARM ASSOC	001	THIORIDAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	30MG/ML	THIORIDAZINE HYDROCHLORIDE	1997-08-28	Discontinued	No
040177	ANDA	PHARM ASSOC	001	TRIHEXYPHENIDYL HYDROCHLORIDE	ELIXIR;ORAL	2MG/5ML	TRIHEXYPHENIDYL HYDROCHLORIDE	1997-04-17	Prescription	Yes
074553	ANDA	PHARM ASSOC	001	CIMETIDINE HYDROCHLORIDE	SOLUTION;ORAL	EQ 300MG BASE/5ML	CIMETIDINE HYDROCHLORIDE	1997-01-27	Discontinued	No
020702	NDA	UPJOHN	001	LIPITOR	TABLET;ORAL	EQ 10MG BASE	ATORVASTATIN CALCIUM	1996-12-17	Prescription	No
			002	LIPITOR	TABLET;ORAL	EQ 20MG BASE	ATORVASTATIN CALCIUM	1996-12-17	Prescription	No
			003	LIPITOR	TABLET;ORAL	EQ 40MG BASE	ATORVASTATIN CALCIUM	1996-12-17	Prescription	No
			004	LIPITOR	TABLET;ORAL	EQ 80MG BASE	ATORVASTATIN CALCIUM	1996-12-17	Prescription	Yes
074725	ANDA	PHARM ASSOC	001	FLUPHENAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	5MG/ML	FLUPHENAZINE HYDROCHLORIDE	1996-09-16	Prescription	Yes
040146	ANDA	PHARM ASSOC	001	FLUPHENAZINE HYDROCHLORIDE	ELIXIR;ORAL	2.5MG/5ML	FLUPHENAZINE HYDROCHLORIDE	1996-08-21	Prescription	Yes
074623	ANDA	PHARM ASSOC	001	LACTULOSE	SOLUTION;ORAL	10GM/15ML	LACTULOSE	1996-07-30	Prescription	Yes
020597	NDA	UPJOHN	001	XALATAN	SOLUTION/DROPS;OPHTHALMIC	0.005%	LATANOPROST	1996-06-05	Prescription	Yes
074522	ANDA	PHARM ASSOC	001	CHLORHEXIDINE GLUCONATE	SOLUTION;DENTAL	0.12%	CHLORHEXIDINE GLUCONATE	1995-12-15	Prescription	No
074509	ANDA	PHARM ASSOC	001	AMANTADINE HYDROCHLORIDE	SYRUP;ORAL	50MG/5ML	AMANTADINE HYDROCHLORIDE	1995-07-17	Prescription	Yes
020305	NDA	ROCHE	001	KYTRIL	TABLET;ORAL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	1995-03-16	Discontinued	No
020305	NDA	ROCHE	002	KYTRIL	TABLET;ORAL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	1995-03-16	Discontinued	No
020239	NDA	ROCHE	001	KYTRIL	INJECTABLE;INJECTION	EQ 3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	1993-12-29	Discontinued	No
			002	KYTRIL	INJECTABLE;INJECTION	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	1993-12-29	Discontinued	No
			003	KYTRIL	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	1993-12-29	Discontinued	No
			004	KYTRIL	INJECTABLE;INJECTION	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GRANISETRON HYDROCHLORIDE	1993-12-29	Discontinued	No
020137	NDA	ROCHE	001	DEMADEX	SOLUTION;INTRAVENOUS	20MG/2ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TORSEMIDE	1993-08-23	Discontinued	No
020137	NDA	ROCHE	002	DEMADEX	SOLUTION;INTRAVENOUS	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TORSEMIDE	1993-08-23	Discontinued	No
073037	ANDA	PHARM ASSOC	001	HALOPERIDOL	CONCENTRATE;ORAL	EQ 2MG BASE/ML	HALOPERIDOL LACTATE	1993-02-26	Prescription	Yes
020199	NDA	ROCHE	001	HIVID	TABLET;ORAL	0.375MG	ZALCITABINE	1992-06-19	Discontinued	No
020199	NDA	ROCHE	002	HIVID	TABLET;ORAL	0.75MG	ZALCITABINE	1992-06-19	Discontinued	No
073026	ANDA	HLTHCARE	001	ATENOLOL	TABLET;ORAL	100MG	ATENOLOL	1991-09-17	Prescription	No
			002	ATENOLOL	TABLET;ORAL	25MG	ATENOLOL	1991-09-17	Prescription	No
			003	ATENOLOL	TABLET;ORAL	50MG	ATENOLOL	1991-09-17	Prescription	No
019358	NDA	ROCHE	001	AZO GANTRISIN	TABLET;ORAL	50MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE	1990-08-31	Discontinued	No
019591	NDA	ROCHE	001	LARIAM	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	MEFLOQUINE HYDROCHLORIDE	1989-05-02	Discontinued	No
089647	ANDA	PHARM ASSOC	001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	SYRUP;ORAL	10MG/5ML;6.25MG/5ML	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	1988-12-22	Discontinued	No
018550	NDA	ROCHE	002	RIMADYL	TABLET;ORAL	100MG	CARPROFEN	1987-12-31	Discontinued	No
018550	NDA	ROCHE	003	RIMADYL	TABLET;ORAL	150MG	CARPROFEN	1987-12-31	Discontinued	No
019369	NDA	ROCHE	001	TEGISON	CAPSULE;ORAL	10MG	ETRETINATE	1986-09-30	Discontinued	No
019369	NDA	ROCHE	002	TEGISON	CAPSULE;ORAL	25MG	ETRETINATE	1986-09-30	Discontinued	No
088584	ANDA	PHARM RES ASSOC	001	DHC PLUS	CAPSULE;ORAL	356.4MG;30MG;16MG	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	1986-03-04	Discontinued	No
020145	NDA	USPHARMA	001	NITRO-DUR	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/HR	NITROGLYCERIN	1985-12-10	Prescription	Yes
			002	NITRO-DUR	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/HR	NITROGLYCERIN	1985-12-10	Prescription	Yes
			003	NITRO-DUR	FILM, EXTENDED RELEASE;TRANSDERMAL	0.3MG/HR	NITROGLYCERIN	1985-12-10	Prescription	Yes
			004	NITRO-DUR	FILM, EXTENDED RELEASE;TRANSDERMAL	0.4MG/HR	NITROGLYCERIN	1985-12-10	Prescription	Yes
			005	NITRO-DUR	FILM, EXTENDED RELEASE;TRANSDERMAL	0.6MG/HR	NITROGLYCERIN	1985-12-10	Prescription	Yes
			006	NITRO-DUR	FILM, EXTENDED RELEASE;TRANSDERMAL	0.8MG/HR	NITROGLYCERIN	1985-12-10	Prescription	Yes
088253	ANDA	PHARM RES ASSOC	001	T-PHYL	TABLET, EXTENDED RELEASE;ORAL	200MG	THEOPHYLLINE	1983-08-17	Discontinued	No
018615	NDA	PHARM ASSOC	002	SULFATRIM	SUSPENSION;ORAL	200MG/5ML;40MG/5ML	SULFAMETHOXAZOLE; TRIMETHOPRIM	1983-01-07	Discontinued	No
018615	NDA	PHARM ASSOC	001	SULFATRIM PEDIATRIC	SUSPENSION;ORAL	200MG/5ML;40MG/5ML	SULFAMETHOXAZOLE; TRIMETHOPRIM	1983-01-07	Prescription	No
062362	ANDA	LIFE LABS	001	ERYTHROMYCIN ESTOLATE	SUSPENSION;ORAL	EQ 250MG BASE/5ML	ERYTHROMYCIN ESTOLATE	1982-12-17	Discontinued	No
087513	ANDA	PHARM ASSOC	001	DIPHENHYDRAMINE HYDROCHLORIDE	ELIXIR;ORAL	12.5MG/5ML	DIPHENHYDRAMINE HYDROCHLORIDE	1982-02-10	Prescription	Yes
018557	NDA	ROCHE	001	FANSIDAR	TABLET;ORAL	25MG;500MG	PYRIMETHAMINE; SULFADOXINE	1981-10-28	Discontinued	No
018276	NDA	UPJOHN	001	XANAX	TABLET;ORAL	0.25MG	ALPRAZOLAM	1981-10-16	Prescription	No
			002	XANAX	TABLET;ORAL	0.5MG	ALPRAZOLAM	1981-10-16	Prescription	No
			003	XANAX	TABLET;ORAL	1MG	ALPRAZOLAM	1981-10-16	Prescription	Yes
			004	XANAX	TABLET;ORAL	2MG	ALPRAZOLAM	1981-10-16	Prescription	No
086720	ANDA	PHARM ASSOC	001	THEOPHYLLINE	ELIXIR;ORAL	80MG/15ML	THEOPHYLLINE	1980-06-25	Discontinued	No
017952	NDA	ROCHE	001	TRIMPEX	TABLET;ORAL	100MG	TRIMETHOPRIM	1980-05-30	Discontinued	No
017952	NDA	ROCHE	002	TRIMPEX 200	TABLET;ORAL	200MG	TRIMETHOPRIM	1980-05-30	Discontinued	No
086760	ANDA	PHARM RES ASSOC	001	PHYLLOCONTIN	TABLET, EXTENDED RELEASE;ORAL	225MG	AMINOPHYLLINE	1979-11-21	Discontinued	No
085303	ANDA	ROCHE	001	ENDEP	TABLET;ORAL	150MG	AMITRIPTYLINE HYDROCHLORIDE	1976-12-27	Discontinued	No
017546	NDA	ROCHE	001	NIPRIDE	INJECTABLE;INJECTION	50MG/VIAL	SODIUM NITROPRUSSIDE	1974-05-10	Discontinued	No
016912	NDA	ROCHE	001	LARODOPA	CAPSULE;ORAL	250MG	LEVODOPA	1970-06-04	Discontinued	No
			002	LARODOPA	CAPSULE;ORAL	100MG	LEVODOPA	1970-06-04	Discontinued	No
			003	LARODOPA	TABLET;ORAL	250MG	LEVODOPA	1970-06-04	Discontinued	No
			004	LARODOPA	TABLET;ORAL	500MG	LEVODOPA	1970-06-04	Discontinued	No
			005	LARODOPA	TABLET;ORAL	100MG	LEVODOPA	1970-06-04	Discontinued	No
			006	LARODOPA	CAPSULE;ORAL	500MG	LEVODOPA	1970-06-04	Discontinued	No
087517	ANDA	PHARM ASSOC	001	BROMPHENIRAMINE MALEATE	ELIXIR;ORAL	2MG/5ML	BROMPHENIRAMINE MALEATE		Discontinued	No
087520	ANDA	PHARM ASSOC	001	CHLORPHENIRAMINE MALEATE	SYRUP;ORAL	2MG/5ML	CHLORPHENIRAMINE MALEATE		Discontinued	No
086823	ANDA	PHARM ASSOC	001	H-CORT	CREAM;TOPICAL	0.5%	HYDROCORTISONE		Discontinued	No
086824	ANDA	PHARM ASSOC	001	H-CORT	LOTION;TOPICAL	0.5%	HYDROCORTISONE		Discontinued	No
087518	ANDA	PHARM ASSOC	001	PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	6.25MG/5ML	PROMETHAZINE HYDROCHLORIDE		Discontinued	No
087514	ANDA	PHARM ASSOC	001	TRIPROLIDINE HYDROCHLORIDE	SYRUP;ORAL	1.25MG/5ML	TRIPROLIDINE HYDROCHLORIDE		Discontinued	No
011771	NDA	PHARM RES ASSOC	001	ATHROMBIN	TABLET;ORAL	25MG	WARFARIN SODIUM		Discontinued	No
			002	ATHROMBIN	TABLET;ORAL	10MG	WARFARIN SODIUM		Discontinued	No
			003	ATHROMBIN	TABLET;ORAL	5MG	WARFARIN SODIUM		Discontinued	No
			004	ATHROMBIN-K	TABLET;ORAL	5MG	WARFARIN POTASSIUM		Discontinued	No
			005	ATHROMBIN-K	TABLET;ORAL	10MG	WARFARIN POTASSIUM		Discontinued	No
			006	ATHROMBIN-K	TABLET;ORAL	25MG	WARFARIN POTASSIUM		Discontinued	No
			007	ATHROMBIN-K	TABLET;ORAL	2MG	WARFARIN POTASSIUM		Discontinued	No
011642	NDA	PHARM RES ASSOC	002	CARDIOQUIN	TABLET;ORAL	275MG	QUINIDINE POLYGALACTURONATE		Discontinued	No
011695	NDA	PHARM RES ASSOC	002	PHENY-PAS-TEBAMIN	POWDER;ORAL	50%	PHENYL AMINOSALICYLATE		Discontinued	No
011695	NDA	PHARM RES ASSOC	003	PHENY-PAS-TEBAMIN	TABLET;ORAL	500MG	PHENYL AMINOSALICYLATE		Discontinued	No
013093	NDA	PHARM RES ASSOC	001	SULFABID	SUSPENSION;ORAL	500MG/5ML	SULFAPHENAZOLE		Discontinued	No
013294	NDA	ROCHE	001	AZO GANTANOL	TABLET;ORAL	100MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE		Discontinued	No
050565	NDA	ROCHE	001	COACTIN	INJECTABLE;INJECTION	250MG/VIAL	AMDINOCILLIN		Discontinued	No
			002	COACTIN	INJECTABLE;INJECTION	500MG/VIAL	AMDINOCILLIN		Discontinued	No
			003	COACTIN	INJECTABLE;INJECTION	1GM/VIAL	AMDINOCILLIN		Discontinued	No
083639	ANDA	ROCHE	001	ENDEP	TABLET;ORAL	10MG	AMITRIPTYLINE HYDROCHLORIDE		Discontinued	No
			002	ENDEP	TABLET;ORAL	25MG	AMITRIPTYLINE HYDROCHLORIDE		Discontinued	No
			003	ENDEP	TABLET;ORAL	50MG	AMITRIPTYLINE HYDROCHLORIDE		Discontinued	No
			004	ENDEP	TABLET;ORAL	75MG	AMITRIPTYLINE HYDROCHLORIDE		Discontinued	No
			005	ENDEP	TABLET;ORAL	100MG	AMITRIPTYLINE HYDROCHLORIDE		Discontinued	No
085749	ANDA	ROCHE	001	ENDEP	CONCENTRATE;ORAL	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMITRIPTYLINE HYDROCHLORIDE		Discontinued	No
006917	NDA	ROCHE	001	GANTRISIN	INJECTABLE;INJECTION	EQ 400MG BASE/ML	SULFISOXAZOLE DIOLAMINE		Discontinued	No
007757	NDA	ROCHE	002	GANTRISIN	SOLUTION/DROPS;OPHTHALMIC	EQ 4% BASE	SULFISOXAZOLE DIOLAMINE		Discontinued	No
008414	NDA	ROCHE	002	GANTRISIN	OINTMENT;OPHTHALMIC	EQ 4% BASE	SULFISOXAZOLE DIOLAMINE		Discontinued	No
011745	NDA	ROCHE	001	KONAKION	INJECTABLE;INJECTION	1MG/0.5ML	PHYTONADIONE		Discontinued	No
011745	NDA	ROCHE	003	KONAKION	INJECTABLE;INJECTION	10MG/ML	PHYTONADIONE		Discontinued	No
010355	NDA	ROCHE	001	QUARZAN	CAPSULE;ORAL	2.5MG	CLIDINIUM BROMIDE		Discontinued	No
010355	NDA	ROCHE	002	QUARZAN	CAPSULE;ORAL	5MG	CLIDINIUM BROMIDE		Discontinued	No
008420	NDA	ROCHE	001	RIMIFON	SYRUP;ORAL	50MG/5ML	ISONIAZID		Discontinued	No
			002	RIMIFON	INJECTABLE;INJECTION	25MG/ML	ISONIAZID		Discontinued	No
			003	RIMIFON	INJECTABLE;INJECTION	100MG/ML	ISONIAZID		Discontinued	No
062510	ANDA	ROCHE	001	ROCEPHIN	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	CEFTRIAXONE SODIUM		Discontinued	No
			002	ROCEPHIN	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	CEFTRIAXONE SODIUM		Discontinued	No
			003	ROCEPHIN	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	CEFTRIAXONE SODIUM		Discontinued	No
017589	NDA	ROCHE	001	SOLATENE	CAPSULE;ORAL	30MG	BETA CAROTENE		Discontinued	No
018179	NDA	ROCHE	001	VALRELEASE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	DIAZEPAM		Discontinued	No
016149	NDA	ROCHE	002	TARACTAN	CONCENTRATE;ORAL	100MG/5ML	CHLORPROTHIXENE	1967-06-19	Discontinued	No
016087	NDA	ROCHE	001	VALIUM	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DIAZEPAM	1966-08-24	Discontinued	No
014740	NDA	ROCHE	006	MENRIUM 10-4	TABLET;ORAL	10MG;0.4MG	CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED	1966-07-28	Discontinued	No
			002	MENRIUM 5-2	TABLET;ORAL	5MG;0.2MG	CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED	1966-07-28	Discontinued	No
			004	MENRIUM 5-4	TABLET;ORAL	5MG;0.4MG	CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED	1966-07-28	Discontinued	No
012715	NDA	ROCHE	002	GANTANOL	TABLET;ORAL	500MG	SULFAMETHOXAZOLE	1965-08-25	Discontinued	No
012715	NDA	ROCHE	003	GANTANOL-DS	TABLET;ORAL	1GM	SULFAMETHOXAZOLE	1965-08-25	Discontinued	No
013664	NDA	ROCHE	002	GANTANOL	SUSPENSION;ORAL	500MG/5ML	SULFAMETHOXAZOLE	1965-07-01	Discontinued	No
012486	NDA	ROCHE	001	TARACTAN	TABLET;ORAL	100MG	CHLORPROTHIXENE	1962-05-07	Discontinued	No
			003	TARACTAN	TABLET;ORAL	50MG	CHLORPROTHIXENE	1962-05-07	Discontinued	No
			004	TARACTAN	TABLET;ORAL	25MG	CHLORPROTHIXENE	1962-05-07	Discontinued	No
			005	TARACTAN	TABLET;ORAL	10MG	CHLORPROTHIXENE	1962-05-07	Discontinued	No
012487	NDA	ROCHE	001	TARACTAN	INJECTABLE;INJECTION	12.5MG/ML	CHLORPROTHIXENE	1962-03-23	Discontinued	No
011340	NDA	PHARM RES ASSOC	002	CERUMENEX	SOLUTION/DROPS;OTIC	10%	TROLAMINE POLYPEPTIDE OLEATE CONDENSATE	1958-06-25	Discontinued	No
010423	NDA	ROCHE	001	LORFAN	INJECTABLE;INJECTION	1MG/ML	LEVALLORPHAN TARTRATE	1956-04-30	Discontinued	No
009660	NDA	ROCHE	002	NOLUDAR	TABLET;ORAL	50MG	METHYPRYLON	1955-01-18	Discontinued	No
			004	NOLUDAR	TABLET;ORAL	200MG	METHYPRYLON	1955-01-18	Discontinued	No
			007	NOLUDAR	ELIXIR;ORAL	50MG/5ML	METHYPRYLON	1955-01-18	Discontinued	No
			008	NOLUDAR	CAPSULE;ORAL	300MG	METHYPRYLON	1955-01-18	Discontinued	No
008983	NDA	ROCHE	001	ARFONAD	INJECTABLE;INJECTION	50MG/ML	TRIMETHAPHAN CAMSYLATE	1954-04-26	Discontinued	No
009182	NDA	ROCHE	002	GANTRISIN	SYRUP;ORAL	EQ 500MG BASE/5ML	SULFISOXAZOLE ACETYL	1953-12-04	Discontinued	No
			004	GANTRISIN PEDIATRIC	SUSPENSION;ORAL	EQ 500MG BASE/5ML	SULFISOXAZOLE ACETYL	1953-12-04	Discontinued	No
			009	LIPO GANTRISIN	EMULSION;ORAL	EQ 1GM BASE/5ML	SULFISOXAZOLE ACETYL	1953-12-04	Discontinued	No
006525	NDA	ROCHE	001	GANTRISIN	TABLET;ORAL	500MG	SULFISOXAZOLE	1948-07-29	Discontinued	No
006071	NDA	ROCHE	003	BEROCCA PN	INJECTABLE;INJECTION	50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML	ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E	1947-07-28	Discontinued	No
003718	NDA	ROCHE	004	SYNKAYVITE	INJECTABLE;INJECTION	5MG/ML	MENADIOL SODIUM DIPHOSPHATE	1941-07-15	Discontinued	No
			006	SYNKAYVITE	INJECTABLE;INJECTION	10MG/ML	MENADIOL SODIUM DIPHOSPHATE	1941-07-15	Discontinued	No
			008	SYNKAYVITE	INJECTABLE;INJECTION	37.5MG/ML	MENADIOL SODIUM DIPHOSPHATE	1941-07-15	Discontinued	No
			010	SYNKAYVITE	TABLET;ORAL	5MG	MENADIOL SODIUM DIPHOSPHATE	1941-07-15	Discontinued	No