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Serving leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
Chubb
Colorcon
Teva
Novartis
QuintilesIMS
Cerilliant
Harvard Business School
Express Scripts

Generated: December 12, 2017

DrugPatentWatch Database Preview

Drug Master Files for: mexiletine

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DMF No. Status Type Submission Date Holder Subject
9257AII7/26/1991MEDICHEM SAMEXILETINE HYDROCHLORIDE
9786III6/30/1992FINE CHEMICALS CORPMEXILETINE HYDROCHLORIDE
10376III7/26/1993ICN HUNGARY COMPANY LTDMEXILETINE HYDROCHLORIDE USP BULK
14442III10/7/1999SLOVAKOFARMA ASMEXILETINE HYDROCHLORIDE
24714AII3/9/2011ALEMBIC PHARMACEUTICALS LTDMEXILETINE HYDROCHLORIDE USP
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Federal Trade Commission
Colorcon
Merck
Daiichi Sankyo
Citi
Johnson and Johnson
Dow
Julphar
Moodys
Baxter

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