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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Cerilliant
Harvard Business School
Queensland Health
Colorcon
Mallinckrodt
Citi
US Army

Generated: April 26, 2018

DrugPatentWatch Database Preview

Drug Master Files for: metaxalone

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metaxalone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
31859 A II 10/24/2017 SUN PHARMACEUTICAL INDUSTRIES LTD METAXALONE USP
5435 I II 6/28/1984 ROCHE DIAGNOSTICS GMBH METAXALONE
6530 I II 7/25/1986 BOEHRINGER INGELHEIM CHEMICALS INC METAXALONE
14394 I II 9/8/1999 DABUR INDIA LTD MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR G OF METAXALONE IN KALYANI DIST NADIA WEST BENGAL INDIA
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Daiichi Sankyo
McKesson
QuintilesIMS
Cerilliant
Farmers Insurance
Dow
Fuji
Boehringer Ingelheim
Cantor Fitzgerald

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