Drug Master Files for: TOPIRAMATE

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TOPIRAMATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10919	A	II	5/27/1994	JANSSEN PHARMACEUTICA NV	TOPIRAMATE DRUG SUBSTANCE
10978	I	II	7/8/1994	CILAG AG	TOPIRAMATE
15658	I	II	10/8/2001	FERRO PFANSTIEHL LABORATORIES INC	TOPIRAMATE
15693	A	II	10/31/2001	CIPLA LTD	TOPIRAMATE USP
16405	I	II	1/30/2003	ALKALOIDA CHEMICAL CO ZRT	TOPIRAMATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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