Drug Master Files for: acamprosate calcium

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acamprosate calcium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11995	I	II	6/10/1996	MERCK SANTE SAS	CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE
15819	I	II	1/23/2002	LIPHA SAS	HOMOTAURINE (CALCIUM ACAMPROSATE INTERMEDIATE)
21348	A	II	2/20/2008	ANGELINI ACRAF SPA	ACAMPROSATE CALCIUM
21481	A	II	3/24/2008	IND SWIFT LABORATORIES LTD	ACAMPROSATE CALCIUM
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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