Drug Master Files for: PREGABALIN

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PREGABALIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22111	A	II	10/23/2008	MSN PHARMACHEM PRIVATE LTD	PREGABALIN USP [ROUTE CODE - PB]
22128	A	II	11/27/2008	SUN PHARMACEUTICAL INDUSTRIES LTD	PREGABALIN
22165	A	II	11/10/2008	MYLAN LABORATORIES LTD	(S)-PREGABALIN
22223	A	II	11/24/2008	CHANGZHOU PHARMACEUTICAL FACTORY	PREGABALIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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