Application 202229

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACAMPROSATE CALCIUM	ACAMPROSATE CALCIUM	TABLET, DELAYED RELEASE;ORAL	333MG	No	Yes

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7213	Acamprosate Calcium	Acamprosate Calcium	Major Pharmaceuticals	ANDA	Current
10135-636	Acamprosate Calcium	Acamprosate Calcium	Marlex Pharmaceuticals Inc	ANDA	Current
10135-636	Acamprosate Calcium	Acamprosate Calcium	Marlex Pharmaceuticals Inc	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
60687-121	Acamprosate Calcium	Acamprosate Calcium	American Health Packaging	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-435	Acamprosate Calcium	Acamprosate Calcium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Document	Submission type	Date
32209	ORIG	2013-07-18