FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
761467	BLA	MERCK SHARP DOHME	001	KEYTRUDA QLEX	INJECTABLE;INJECTION	395MG/4800UNITS(2.4ML)	PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH	2025-09-19	Prescription	No
761467	BLA	MERCK SHARP DOHME	002	KEYTRUDA QLEX	INJECTABLE;INJECTION	790MG/9600UNITS(4.8ML)	PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH	2025-09-19	Prescription	No
761432	BLA	MERCK SHARP DOHME	001	ENFLONSIA	INJECTION;SOLUTION	105MG/0.7ML	CLESROVIMAB-CFOR	2025-06-09	Prescription	No
761363	BLA	MERCK SHARP DOHME	001	WINREVAIR	INJECTABLE;INJECTION	45MG	SOTATERCEPT-CSRK	2024-03-26	Prescription	No
761363	BLA	MERCK SHARP DOHME	002	WINREVAIR	INJECTABLE;INJECTION	60MG	SOTATERCEPT-CSRK	2024-03-26	Prescription	No
215383	NDA	MERCK SHARP DOHME	001	WELIREG	TABLET;ORAL	40MG	BELZUTIFAN	2021-08-13	Prescription	Yes
214770	NDA	MSD MERCK CO	001	NOXAFIL POWDERMIX KIT	FOR SUSPENSION, DELAYED RELEASE;ORAL	300MG	POSACONAZOLE	2021-05-31	Prescription	Yes
212819	NDA	MSD MERCK CO	001	RECARBRIO	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	CILASTATIN SODIUM; IMIPENEM; RELEBACTAM	2019-07-16	Prescription	Yes
210806	NDA	MSD MERCK CO	001	PIFELTRO	TABLET;ORAL	100MG	DORAVIRINE	2018-08-30	Prescription	Yes
210807	NDA	MSD MERCK CO	001	DELSTRIGO	TABLET;ORAL	100MG;300MG;300MG	DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	2018-08-30	Prescription	Yes
209803	NDA	MSD SUB MERCK	001	STEGLATRO	TABLET;ORAL	5MG	ERTUGLIFLOZIN	2017-12-19	Prescription	No
209803	NDA	MSD SUB MERCK	002	STEGLATRO	TABLET;ORAL	15MG	ERTUGLIFLOZIN	2017-12-19	Prescription	Yes
209805	NDA	MSD SUB MERCK	001	STEGLUJAN	TABLET;ORAL	5MG;EQ 100MG BASE	ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE	2017-12-19	Prescription	No
209805	NDA	MSD SUB MERCK	002	STEGLUJAN	TABLET;ORAL	15MG;EQ 100MG BASE	ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE	2017-12-19	Prescription	Yes
209806	NDA	MSD SUB MERCK	001	SEGLUROMET	TABLET;ORAL	2.5MG;500MG	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2017-12-19	Prescription	No
			002	SEGLUROMET	TABLET;ORAL	2.5MG;1GM	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2017-12-19	Prescription	No
			003	SEGLUROMET	TABLET;ORAL	7.5MG;500MG	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2017-12-19	Prescription	No
			004	SEGLUROMET	TABLET;ORAL	7.5MG;1GM	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	2017-12-19	Prescription	Yes
209939	NDA	MERCK SHARP DOHME	001	PREVYMIS	TABLET;ORAL	240MG	LETERMOVIR	2017-11-08	Prescription	No
209939	NDA	MERCK SHARP DOHME	002	PREVYMIS	TABLET;ORAL	480MG	LETERMOVIR	2017-11-08	Prescription	Yes
209940	NDA	MERCK SHARP DOHME	001	PREVYMIS	SOLUTION;INTRAVENOUS	240MG/12ML (20MG/ML)	LETERMOVIR	2017-11-08	Prescription	Yes
209940	NDA	MERCK SHARP DOHME	002	PREVYMIS	SOLUTION;INTRAVENOUS	480MG/24ML (20MG/ML)	LETERMOVIR	2017-11-08	Prescription	Yes
761046	BLA	MERCK SHARP DOHME	001	ZINPLAVA	INJECTABLE;INJECTION	1000ML/40ML	BEZLOTOXUMAB	2016-10-21	Prescription	No
208261	NDA	MSD SUB MERCK	001	ZEPATIER	TABLET;ORAL	50MG;100MG	ELBASVIR; GRAZOPREVIR	2016-01-28	Prescription	Yes
207865	NDA	MSD MERCK CO	001	EMEND	FOR SUSPENSION;ORAL	125MG/KIT	APREPITANT	2015-12-17	Prescription	Yes
022225	NDA	MSD SUB MERCK	001	BRIDION	SOLUTION;INTRAVENOUS	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SUGAMMADEX SODIUM	2015-12-15	Prescription	Yes
022225	NDA	MSD SUB MERCK	002	BRIDION	SOLUTION;INTRAVENOUS	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SUGAMMADEX SODIUM	2015-12-15	Prescription	No
206510	NDA	MERCK SHARP DOHME	001	DUTREBIS	TABLET;ORAL	150MG;EQ 300MG BASE	LAMIVUDINE; RALTEGRAVIR POTASSIUM	2015-02-06	Discontinued	No
125514	BLA	MERCK SHARP DOHME	001	KEYTRUDA	SOLUTION;INTRAVENOUS	100MG/4ML (25MG/ML)	PEMBROLIZUMAB	2014-09-04	Prescription	No
204569	NDA	MERCK SHARP DOHME	001	BELSOMRA	TABLET;ORAL	5MG	SUVOREXANT	2014-08-13	Prescription	No
			002	BELSOMRA	TABLET;ORAL	10MG	SUVOREXANT	2014-08-13	Prescription	No
			003	BELSOMRA	TABLET;ORAL	15MG	SUVOREXANT	2014-08-13	Prescription	No
			004	BELSOMRA	TABLET;ORAL	20MG	SUVOREXANT	2014-08-13	Prescription	Yes
205596	NDA	MERCK SHARP DOHME	001	NOXAFIL	SOLUTION;INTRAVENOUS	300MG/16.7ML (18MG/ML)	POSACONAZOLE	2014-03-13	Prescription	Yes
205786	NDA	MSD SUB MERCK	001	ISENTRESS	POWDER;ORAL	EQ 100MG BASE/PACKET	RALTEGRAVIR POTASSIUM	2013-12-20	Prescription	Yes
205053	NDA	MERCK SHARP DOHME	001	NOXAFIL	TABLET, DELAYED RELEASE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POSACONAZOLE	2013-11-25	Discontinued	No
202270	NDA	MSD SUB MERCK	001	JANUMET XR	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 50MG BASE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	2012-02-02	Prescription	No
			002	JANUMET XR	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 50MG BASE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	2012-02-02	Prescription	No
			003	JANUMET XR	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 100MG BASE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	2012-02-02	Prescription	Yes
203045	NDA	MSD SUB MERCK	001	ISENTRESS	TABLET, CHEWABLE;ORAL	EQ 25MG BASE	RALTEGRAVIR POTASSIUM	2011-12-21	Prescription	No
203045	NDA	MSD SUB MERCK	002	ISENTRESS	TABLET, CHEWABLE;ORAL	EQ 100MG BASE	RALTEGRAVIR POTASSIUM	2011-12-21	Prescription	Yes
202343	NDA	MERCK SHARP DOHME	001	JUVISYNC	TABLET;ORAL	10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	2011-10-07	Discontinued	No
			002	JUVISYNC	TABLET;ORAL	20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	2011-10-07	Discontinued	No
			003	JUVISYNC	TABLET;ORAL	40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	2011-10-07	Discontinued	No
			004	JUVISYNC	TABLET;ORAL	10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	2011-10-07	Discontinued	No
			005	JUVISYNC	TABLET;ORAL	20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	2011-10-07	Discontinued	No
			006	JUVISYNC	TABLET;ORAL	40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SIMVASTATIN; SITAGLIPTIN PHOSPHATE	2011-10-07	Discontinued	No
202258	NDA	MERCK SHARP DOHME	001	VICTRELIS	CAPSULE;ORAL	200MG	BOCEPREVIR	2011-05-13	Discontinued	No
022277	NDA	MERCK SHARP DOHME	001	TEMODAR	POWDER;INTRAVENOUS	100MG/VIAL	TEMOZOLOMIDE	2009-02-27	Prescription	Yes
022023	NDA	MERCK AND CO INC	001	EMEND	POWDER;INTRAVENOUS	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOSAPREPITANT DIMEGLUMINE	2008-01-25	Discontinued	No
022023	NDA	MERCK AND CO INC	002	EMEND	POWDER;INTRAVENOUS	EQ 150MG BASE/VIAL	FOSAPREPITANT DIMEGLUMINE	2008-01-25	Prescription	Yes
022145	NDA	MSD SUB MERCK	001	ISENTRESS	TABLET;ORAL	EQ 400MG BASE	RALTEGRAVIR POTASSIUM	2007-10-12	Prescription	Yes
022145	NDA	MSD SUB MERCK	002	ISENTRESS HD	TABLET;ORAL	EQ 600MG BASE	RALTEGRAVIR POTASSIUM	2007-10-12	Prescription	Yes
022044	NDA	MSD SUB MERCK	001	JANUMET	TABLET;ORAL	500MG;EQ 50MG BASE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	2007-03-30	Prescription	No
022044	NDA	MSD SUB MERCK	002	JANUMET	TABLET;ORAL	1GM;EQ 50MG BASE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	2007-03-30	Prescription	Yes
021995	NDA	MERCK SHARP DOHME	001	JANUVIA	TABLET;ORAL	EQ 25MG BASE	SITAGLIPTIN PHOSPHATE	2006-10-16	Prescription	No
			002	JANUVIA	TABLET;ORAL	EQ 50MG BASE	SITAGLIPTIN PHOSPHATE	2006-10-16	Prescription	No
			003	JANUVIA	TABLET;ORAL	EQ 100MG BASE	SITAGLIPTIN PHOSPHATE	2006-10-16	Prescription	Yes
021991	NDA	MSD SUB MERCK	001	ZOLINZA	CAPSULE;ORAL	100MG	VORINOSTAT	2006-10-06	Prescription	Yes
076752	ANDA	MERCK KGAA	001	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			002	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			003	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			004	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			005	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			006	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			007	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			008	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			009	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			010	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
			011	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG	LEVOTHYROXINE SODIUM	2005-06-16	Discontinued	No
021300	NDA	MERCK SHARP DOHME	001	CLARINEX	SOLUTION;ORAL	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DESLORATADINE	2004-09-01	Discontinued	No
021647	NDA	MERCK	001	VIOXX	TABLET; ORAL	12.5MG	ROFECOXIB	2004-03-26	Discontinued	No
			002	VIOXX	TABLET; ORAL	25MG	ROFECOXIB	2004-03-26	Discontinued	No
			003	VIOXX	TABLET; ORAL	50MG	ROFECOXIB	2004-03-26	Discontinued	No
021575	NDA	MERCK	001	FOSAMAX	SOLUTION;ORAL	EQ 70MG BASE/75ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ALENDRONATE SODIUM	2003-09-17	Discontinued	No
021337	NDA	MSD SUB MERCK	001	INVANZ	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	ERTAPENEM SODIUM	2001-11-21	Prescription	Yes
021227	NDA	MERCK	001	CANCIDAS	POWDER;INTRAVENOUS	50MG/VIAL	CASPOFUNGIN ACETATE	2001-01-26	Discontinued	No
021227	NDA	MERCK	002	CANCIDAS	POWDER;INTRAVENOUS	70MG/VIAL	CASPOFUNGIN ACETATE	2001-01-26	Discontinued	No
020010	NDA	MERCK SHARP DOHME	001	LOTRISONE	LOTION;TOPICAL	EQ 0.05% BASE;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	2000-12-08	Discontinued	No
021029	NDA	MERCK SHARP DOHME	001	TEMODAR	CAPSULE;ORAL	5MG	TEMOZOLOMIDE	1999-08-11	Discontinued	No
			002	TEMODAR	CAPSULE;ORAL	20MG	TEMOZOLOMIDE	1999-08-11	Discontinued	No
			003	TEMODAR	CAPSULE;ORAL	100MG	TEMOZOLOMIDE	1999-08-11	Discontinued	No
			004	TEMODAR	CAPSULE;ORAL	250MG	TEMOZOLOMIDE	1999-08-11	Discontinued	No
			005	TEMODAR	CAPSULE;ORAL	140MG	TEMOZOLOMIDE	1999-08-11	Discontinued	No
			006	TEMODAR	CAPSULE;ORAL	180MG	TEMOZOLOMIDE	1999-08-11	Discontinued	No
021042	NDA	MERCK	001	VIOXX	TABLET;ORAL	12.5MG	ROFECOXIB	1999-05-20	Discontinued	No
			002	VIOXX	TABLET;ORAL	25MG	ROFECOXIB	1999-05-20	Discontinued	No
			003	VIOXX	TABLET;ORAL	50MG	ROFECOXIB	1999-05-20	Discontinued	No
021052	NDA	MERCK	001	VIOXX	SUSPENSION;ORAL	12.5MG/5ML	ROFECOXIB	1999-05-20	Discontinued	No
021052	NDA	MERCK	002	VIOXX	SUSPENSION;ORAL	25MG/5ML	ROFECOXIB	1999-05-20	Discontinued	No
020903	NDA	MERCK SHARP DOHME	001	REBETOL	CAPSULE;ORAL	200MG Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy	RIBAVIRIN	1998-06-03	Discontinued	No
020903	NDA	MERCK SHARP DOHME	002	REBETOL	CAPSULE;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	RIBAVIRIN	1998-06-03	Discontinued	No
020752	NDA	MERCK	001	PEPCID RPD	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	FAMOTIDINE	1998-05-28	Discontinued	No
020752	NDA	MERCK	002	PEPCID RPD	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	FAMOTIDINE	1998-05-28	Discontinued	No
020718	NDA	MSD SUB MERCK	001	INTEGRILIN	INJECTABLE;INJECTION	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EPTIFIBATIDE	1998-05-18	Discontinued	No
020718	NDA	MSD SUB MERCK	002	INTEGRILIN	INJECTABLE;INJECTION	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EPTIFIBATIDE	1998-05-18	Discontinued	No
050742	NDA	MERCK SHARP DOHME	001	STROMECTOL	TABLET;ORAL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	IVERMECTIN	1996-11-22	Discontinued	No
050742	NDA	MERCK SHARP DOHME	002	STROMECTOL	TABLET;ORAL	3MG	IVERMECTIN	1996-11-22	Prescription	Yes
020506	NDA	MERCK	001	TIAMATE	TABLET, EXTENDED RELEASE;ORAL	EQ 120MG HYDROCHLORIDE	DILTIAZEM MALATE	1996-10-04	Discontinued	No
			002	TIAMATE	TABLET, EXTENDED RELEASE;ORAL	EQ 180MG HYDROCHLORIDE	DILTIAZEM MALATE	1996-10-04	Discontinued	No
			003	TIAMATE	TABLET, EXTENDED RELEASE;ORAL	EQ 240MG HYDROCHLORIDE	DILTIAZEM MALATE	1996-10-04	Discontinued	No
020685	NDA	MERCK SHARP DOHME	001	CRIXIVAN	CAPSULE;ORAL	EQ 400MG BASE	INDINAVIR SULFATE	1996-03-13	Discontinued	No
			003	CRIXIVAN	CAPSULE;ORAL	EQ 200MG BASE	INDINAVIR SULFATE	1996-03-13	Discontinued	No
			005	CRIXIVAN	CAPSULE;ORAL	EQ 333MG BASE	INDINAVIR SULFATE	1996-03-13	Discontinued	No
			006	CRIXIVAN	CAPSULE;ORAL	EQ 100MG BASE	INDINAVIR SULFATE	1996-03-13	Discontinued	No
020408	NDA	MSD SUB MERCK	001	TRUSOPT	SOLUTION/DROPS;OPHTHALMIC	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DORZOLAMIDE HYDROCHLORIDE	1994-12-09	Discontinued	No
020249	NDA	MERCK SHARP DOHME	001	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	INJECTABLE;INJECTION	0.4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FAMOTIDINE	1994-02-18	Discontinued	No
019757	NDA	MERCK	001	CHIBROXIN	SOLUTION/DROPS;OPHTHALMIC	0.3%	NORFLOXACIN	1991-06-17	Discontinued	No
050630	NDA	MERCK	001	PRIMAXIN	POWDER;INTRAMUSCULAR	EQ 500MG BASE/VIAL;500MG/VIAL	CILASTATIN SODIUM; IMIPENEM	1990-12-14	Discontinued	No
050630	NDA	MERCK	002	PRIMAXIN	POWDER;INTRAMUSCULAR	EQ 750MG BASE/VIAL;750MG/VIAL	CILASTATIN SODIUM; IMIPENEM	1990-12-14	Discontinued	No
019778	NDA	MERCK	001	PRINZIDE	TABLET;ORAL	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE; LISINOPRIL	1989-02-16	Discontinued	No
			002	PRINZIDE	TABLET;ORAL	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE; LISINOPRIL	1989-02-16	Discontinued	No
			003	PRINZIDE	TABLET;ORAL	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE; LISINOPRIL	1989-02-16	Discontinued	No
019558	NDA	MERCK	001	PRINIVIL	TABLET;ORAL	5MG	LISINOPRIL	1987-12-29	Discontinued	No
			002	PRINIVIL	TABLET;ORAL	10MG	LISINOPRIL	1987-12-29	Discontinued	No
			003	PRINIVIL	TABLET;ORAL	20MG	LISINOPRIL	1987-12-29	Discontinued	No
			004	PRINIVIL	TABLET;ORAL	40MG	LISINOPRIL	1987-12-29	Discontinued	No
			006	PRINIVIL	TABLET;ORAL	2.5MG	LISINOPRIL	1987-12-29	Discontinued	No
019643	NDA	MERCK	002	MEVACOR	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOVASTATIN	1987-08-31	Discontinued	No
			003	MEVACOR	TABLET;ORAL	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	LOVASTATIN	1987-08-31	Discontinued	No
			004	MEVACOR	TABLET;ORAL	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	LOVASTATIN	1987-08-31	Discontinued	No
062756	ANDA	MERCK	001	PRIMAXIN	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL;250MG/VIAL	CILASTATIN SODIUM; IMIPENEM	1987-01-08	Discontinued	No
062756	ANDA	MERCK	002	PRIMAXIN	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL;500MG/VIAL	CILASTATIN SODIUM; IMIPENEM	1987-01-08	Discontinued	No
019510	NDA	MERCK	001	PEPCID	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FAMOTIDINE	1986-11-04	Discontinued	No
019510	NDA	MERCK	004	PEPCID PRESERVATIVE FREE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FAMOTIDINE	1986-11-04	Discontinued	No
019384	NDA	MERCK	002	NOROXIN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NORFLOXACIN	1986-10-31	Discontinued	No
050587	NDA	MERCK	001	PRIMAXIN	POWDER;INTRAVENOUS	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CILASTATIN SODIUM; IMIPENEM	1985-11-26	Discontinued	No
050587	NDA	MERCK	002	PRIMAXIN	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL;500MG/VIAL	CILASTATIN SODIUM; IMIPENEM	1985-11-26	Prescription	Yes
018445	NDA	MERCK	001	DOLOBID	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DIFLUNISAL	1982-04-19	Discontinued	No
018445	NDA	MERCK	002	DOLOBID	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DIFLUNISAL	1982-04-19	Discontinued	No
018061	NDA	MERCK	001	TIMOLIDE 10-25	TABLET;ORAL	25MG;10MG	HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE	1981-12-11	Discontinued	No
018017	NDA	MERCK	001	BLOCADREN	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TIMOLOL MALEATE	1981-11-25	Discontinued	No
			002	BLOCADREN	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TIMOLOL MALEATE	1981-11-25	Discontinued	No
			004	BLOCADREN	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TIMOLOL MALEATE	1981-11-25	Discontinued	No
018201	NDA	MERCK	001	MODURETIC 5-50	TABLET;ORAL	EQ 5MG ANHYDROUS;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	1981-10-05	Discontinued	No
018389	NDA	MERCK	001	ALDOMET	SUSPENSION;ORAL	250MG/5ML	METHYLDOPA	1981-08-28	Discontinued	No
017911	NDA	MERCK	001	CLINORIL	TABLET;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SULINDAC	1978-09-27	Discontinued	No
017911	NDA	MERCK	002	CLINORIL	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SULINDAC	1978-09-27	Discontinued	No
101063	BLA	MERCK	001	ELSPAR	VIAL	10,000IU/VIAL	ASPARAGINASE	1978-01-10	Prescription	No
080778	ANDA	MERCK	001	ALPHAREDISOL	INJECTABLE;INJECTION	1MG/ML	HYDROXOCOBALAMIN	1975-04-18	Discontinued	No
011958	NDA	MERCK	002	HYDROPRES 25	TABLET;ORAL	25MG;0.125MG	HYDROCHLOROTHIAZIDE; RESERPINE	1974-05-16	Discontinued	No
011958	NDA	MERCK	003	HYDROPRES 50	TABLET;ORAL	50MG;0.125MG	HYDROCHLOROTHIAZIDE; RESERPINE	1974-05-16	Discontinued	No
016675	NDA	MERCK	001	DECADRON-LA	INJECTABLE;INJECTION	EQ 8MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE ACETATE	1973-09-06	Discontinued	No
008472	NDA	MERCK	001	CYCLAINE	SOLUTION;TOPICAL	5%	HEXYLCAINE HYDROCHLORIDE		Discontinued	No
013538	NDA	MERCK	001	DECADERM	GEL;TOPICAL	0.1%	DEXAMETHASONE		Discontinued	No
011028	NDA	MERCK	001	HYDELTRASOL	OINTMENT;OPHTHALMIC, OTIC	EQ 0.25% PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE		Discontinued	No
011583	NDA	MERCK	002	HYDELTRASOL	INJECTABLE;INJECTION	EQ 20MG PHOSPHATE/ML	PREDNISOLONE SODIUM PHOSPHATE		Discontinued	No
009018	NDA	MERCK	003	HYDROCORTONE	OINTMENT;OPHTHALMIC, OTIC	1.5%	HYDROCORTISONE ACETATE		Discontinued	No
010520	NDA	MERCK	003	LERITINE	INJECTABLE;INJECTION	25MG/ML	ANILERIDINE PHOSPHATE		Discontinued	No
005620	NDA	MERCK	001	MANNITOL 25%	INJECTABLE;INJECTION	12.5GM/50ML	MANNITOL		Discontinued	No
050581	NDA	MERCK	003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFOXITIN SODIUM		Discontinued	No
			004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFOXITIN SODIUM		Discontinued	No
			001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFOXITIN SODIUM		Discontinued	No
			002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	INJECTABLE;INJECTION	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CEFOXITIN SODIUM		Discontinued	No
050378	NDA	MERCK	001	NEO-HYDELTRASOL	OINTMENT;OPHTHALMIC	EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE	NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE		Discontinued	No
006668	NDA	MERCK	010	REDISOL	INJECTABLE;INJECTION	1MG/ML	CYANOCOBALAMIN		Discontinued	No
050324	NDA	MERCK	001	NEODECADRON	OINTMENT;OPHTHALMIC	EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM	DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE	1969-09-15	Discontinued	No
050322	NDA	MERCK	001	NEODECADRON	SOLUTION/DROPS;OPHTHALMIC	EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML	DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE	1969-07-02	Discontinued	No
016016	NDA	MERCK	001	ALDOCLOR-150	TABLET;ORAL	150MG;250MG	CHLOROTHIAZIDE; METHYLDOPA	1968-03-20	Discontinued	No
016016	NDA	MERCK	002	ALDOCLOR-250	TABLET;ORAL	250MG;250MG	CHLOROTHIAZIDE; METHYLDOPA	1968-03-20	Discontinued	No
016097	NDA	MERCK SHARP DOHME	001	MINTEZOL	SUSPENSION;ORAL	500MG/5ML	THIABENDAZOLE	1967-04-21	Discontinued	No
016096	NDA	MERCK SHARP DOHME	001	MINTEZOL	TABLET, CHEWABLE;ORAL	500MG	THIABENDAZOLE	1967-04-07	Discontinued	No
014215	NDA	MERCK SHARP DOHME	002	CELESTONE	SYRUP;ORAL	0.6MG/5ML	BETAMETHASONE	1964-04-13	Discontinued	No
013400	NDA	MERCK	001	ALDOMET	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METHYLDOPA	1962-12-20	Discontinued	No
			002	ALDOMET	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METHYLDOPA	1962-12-20	Discontinued	No
			003	ALDOMET	TABLET;ORAL	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METHYLDOPA	1962-12-20	Discontinued	No
013401	NDA	MERCK	001	ALDOMET	INJECTABLE;INJECTION	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METHYLDOPATE HYDROCHLORIDE	1962-12-20	Discontinued	No
013402	NDA	MERCK	001	ALDORIL 15	TABLET;ORAL	15MG;250MG	HYDROCHLOROTHIAZIDE; METHYLDOPA	1962-12-20	Discontinued	No
			002	ALDORIL 25	TABLET;ORAL	25MG;250MG	HYDROCHLOROTHIAZIDE; METHYLDOPA	1962-12-20	Discontinued	No
			003	ALDORIL D30	TABLET;ORAL	30MG;500MG	HYDROCHLOROTHIAZIDE; METHYLDOPA	1962-12-20	Discontinued	No
			004	ALDORIL D50	TABLET;ORAL	50MG;500MG	HYDROCHLOROTHIAZIDE; METHYLDOPA	1962-12-20	Discontinued	No
013334	NDA	MERCK	002	DECADRON W/ XYLOCAINE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML;10MG/ML	DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE	1962-07-11	Discontinued	No
013220	NDA	MERCK	002	PERIACTIN	SYRUP;ORAL	2MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CYPROHEPTADINE HYDROCHLORIDE	1962-03-30	Discontinued	No
012649	NDA	MERCK	001	PERIACTIN	TABLET;ORAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CYPROHEPTADINE HYDROCHLORIDE	1961-10-17	Discontinued	No
012383	NDA	MERCK	001	COLBENEMID	TABLET;ORAL	0.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	COLCHICINE; PROBENECID	1961-07-27	Discontinued	No
012731	NDA	MERCK	002	DECASPRAY	AEROSOL;TOPICAL	0.04% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1961-03-29	Discontinued	No
012376	NDA	MERCK	002	DECADRON	ELIXIR;ORAL	0.5MG/5ML	DEXAMETHASONE	1960-07-07	Discontinued	No
012052	NDA	MERCK	001	HYDROCORTONE	INJECTABLE;INJECTION	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCORTISONE SODIUM PHOSPHATE	1960-06-08	Discontinued	No
012071	NDA	MERCK	002	DECADRON	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE SODIUM PHOSPHATE	1959-10-06	Discontinued	No
012071	NDA	MERCK	004	DECADRON	INJECTABLE;INJECTION	EQ 24MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE SODIUM PHOSPHATE	1959-10-06	Discontinued	No
011977	NDA	MERCK	001	DECADRON	OINTMENT;OPHTHALMIC	EQ 0.05% PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	1959-09-02	Discontinued	No
011984	NDA	MERCK	001	DECADRON	SOLUTION/DROPS;OPHTHALMIC, OTIC	EQ 0.1% PHOSPHATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE SODIUM PHOSPHATE	1959-09-02	Discontinued	No
011983	NDA	MERCK	002	DECADRON	CREAM;TOPICAL	EQ 0.1% PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	1959-08-26	Discontinued	No
011860	NDA	MERCK	001	HUMORSOL	SOLUTION/DROPS;OPHTHALMIC	0.25%	DEMECARIUM BROMIDE	1959-08-05	Discontinued	No
011860	NDA	MERCK	002	HUMORSOL	SOLUTION/DROPS;OPHTHALMIC	0.125%	DEMECARIUM BROMIDE	1959-08-05	Discontinued	No
011835	NDA	MERCK	003	HYDRODIURIL	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE	1959-02-24	Discontinued	No
			006	HYDRODIURIL	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE	1959-02-24	Discontinued	No
			007	HYDRODIURIL	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	HYDROCHLOROTHIAZIDE	1959-02-24	Discontinued	No
011635	NDA	MERCK	003	DIUPRES-250	TABLET;ORAL	250MG;0.125MG	CHLOROTHIAZIDE; RESERPINE	1958-12-11	Discontinued	No
011635	NDA	MERCK	006	DIUPRES-500	TABLET;ORAL	500MG;0.125MG	CHLOROTHIAZIDE; RESERPINE	1958-12-11	Discontinued	No
011664	NDA	MERCK	001	DECADRON	TABLET;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1958-10-30	Discontinued	No
			002	DECADRON	TABLET;ORAL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1958-10-30	Discontinued	No
			003	DECADRON	TABLET;ORAL	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1958-10-30	Discontinued	No
			004	DECADRON	TABLET;ORAL	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1958-10-30	Discontinued	No
			005	DECADRON	TABLET;ORAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1958-10-30	Discontinued	No
			006	DECADRON	TABLET;ORAL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	DEXAMETHASONE	1958-10-30	Discontinued	No
010585	NDA	MERCK	002	LERITINE	TABLET;ORAL	EQ 25MG BASE	ANILERIDINE HYDROCHLORIDE	1957-08-15	Discontinued	No
010656	NDA	MERCK	001	FLOROPRYL	OINTMENT;OPHTHALMIC	0.025%	ISOFLUROPHATE	1957-04-02	Discontinued	No
010562	NDA	MERCK	001	HYDELTRA-TBA	INJECTABLE;INJECTION	20MG/ML	PREDNISOLONE TEBUTATE	1956-07-25	Discontinued	No
009509	NDA	MERCK	002	ARAMINE	INJECTABLE;INJECTION	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	METARAMINOL BITARTRATE	1954-09-29	Discontinued	No
009193	NDA	MERCK	002	COGENTIN	TABLET;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BENZTROPINE MESYLATE	1954-03-05	Discontinued	No
			003	COGENTIN	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BENZTROPINE MESYLATE	1954-03-05	Discontinued	No
			004	COGENTIN	TABLET;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	BENZTROPINE MESYLATE	1954-03-05	Discontinued	No
008506	NDA	MERCK	007	HYDROCORTONE	TABLET;ORAL	10MG	HYDROCORTISONE	1952-08-05	Discontinued	No
008506	NDA	MERCK	011	HYDROCORTONE	TABLET;ORAL	20MG	HYDROCORTISONE	1952-08-05	Discontinued	No
008228	NDA	MERCK	001	HYDROCORTONE	INJECTABLE;INJECTION	25MG/ML	HYDROCORTISONE ACETATE	1951-12-21	Discontinued	No
008228	NDA	MERCK	004	HYDROCORTONE	INJECTABLE;INJECTION	50MG/ML	HYDROCORTISONE ACETATE	1951-12-21	Discontinued	No
007898	NDA	MERCK	004	BENEMID	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROBENECID	1951-04-26	Discontinued	No
007750	NDA	MERCK	003	CORTONE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CORTISONE ACETATE	1950-12-04	Discontinued	No
007110	NDA	MERCK	002	CORTONE	INJECTABLE;INJECTION	25MG/ML	CORTISONE ACETATE	1950-06-13	Discontinued	No
007110	NDA	MERCK	003	CORTONE	INJECTABLE;INJECTION	50MG/ML	CORTISONE ACETATE	1950-06-13	Discontinued	No
005619	NDA	MERCK	001	AMINOHIPPURATE SODIUM	INJECTABLE;INJECTION	20%	AMINOHIPPURATE SODIUM	1944-12-30	Discontinued	No
001546	NDA	MERCK SHARP DOHME	001	GUANIDINE HYDROCHLORIDE	TABLET;ORAL	125MG	GUANIDINE HYDROCHLORIDE	1939-10-02	Discontinued	No