Drug Master Files for: METFORMIN HYDROCHLORIDE

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METFORMIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11924	I	II	4/17/1996	GROUPE LIPHA	METFORMIN HYDROCHLORIDE
12647	A	II	9/8/1997	USV PRIVATE LTD	METFORMIN HCL USP
12670	A	II	9/30/1997	MERCK SANTE SAS	METFORMIN HYDROCHLORIDE DRUG SUBTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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