Drug Master Files for: VIGABATRIN

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VIGABATRIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21579	I	II	4/29/2008	DIVIS LABORATORIES LTD	VIGABATRIN
27240	A	II	6/29/2013	MSN LABORATORIES PRIVATE LTD	VIGABATRIN USP [ROUTE CODE - VB]
31953	A	II	7/29/2017	DIVIS LABORATORIES LTD	VIGABATRIN USP
33154	A	II	9/22/2018	SIONC PHARMACEUTICALS PVT LTD	VIGABATRIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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