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Generated: November 17, 2018

DrugPatentWatch Database Preview

Drug Master Files for: carbamazepine

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carbamazepine Drug Master Files

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
15195 A II 12/4/2000 SIEGFRIED EVIONNAZ SA CARBAMAZEPINE (CARBATOL)
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
QuintilesIMS
Argus Health
Chubb
Citi
Healthtrust
Colorcon
Deloitte
Mallinckrodt

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