Application 019268

Type: NDA
Sponsor: GD SEARLE LLC

Related Records

Company: GD SEARLE LLC

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTOTEC	MISOPROSTOL	TABLET;ORAL	0.2MG	Yes	Yes
003	CYTOTEC	MISOPROSTOL	TABLET;ORAL	0.1MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
12634-502	misoprostol	MISOPROSTOL	Apotheca Inc.	NDA AUTHORIZED GENERIC	Current
12634-933	CYTOTEC	MISOPROSTOL	Apotheca, Inc	NDA	Current
43393-020	misoprostol	MISOPROSTOL	GenBioPro, Inc.	NDA AUTHORIZED GENERIC	Current
43393-020	misoprostol	MISOPROSTOL	GenBioPro, Inc.	NDA AUTHORIZED GENERIC	Current
52959-692	misoprostol	misoprostol	H.J. Harkins Company, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, In	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
59762-5007	misoprostol	MISOPROSTOL	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5008	misoprostol	MISOPROSTOL	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
66336-608	misoprostol	MISOPROSTOL	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current
72789-111	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-111	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-111	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents

Document	Submission type	Date
52779	SUPPL	2018-03-01
52774	SUPPL	2018-03-01
46223	SUPPL	2016-12-19
46222	SUPPL	2016-12-19
11465	SUPPL	2012-11-26
17344	SUPPL	2012-11-21
40882	ORIG	2011-12-16
1267	SUPPL	2009-11-12
33713	SUPPL	2009-10-06
44030	ORIG	2005-07-29
17343	SUPPL	2003-08-14
17342	SUPPL	2003-08-14
17341	SUPPL	2002-04-17
11464	SUPPL	2002-04-17