Drug Master Files for: CARBAMAZEPINE

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CARBAMAZEPINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11901	I	II	3/26/1996	ARZNEIMITTELWERK DRESDEN GMBH	CARBAMAZEPINE
12512	I	II	5/21/1997	MAX INDIA LTD	CARBAMAZEPINE BULK DRUG SUBSTANCE
13125	I	II	8/11/1998	TEVA GROUP	CARBAMAZEPINE USP
14410	A	II	9/21/1999	JUBILANT GENERICS LTD	CARBAMAZEPINE USP
14893	I	II	5/19/2000	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	CARBAMAZEPINE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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