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Generated: May 21, 2019

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Drug Master Files for: baclofen

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baclofen Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12438 I II 3/12/1997 PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA BACLOFEN
12541 A II 4/17/1997 FINE CHEMICALS CORP PTY LTD (R)-(-)-BACLOFEN
18014 A II 1/20/2005 ZAKLADY FARMACEUTYCZNE POLPHARMA SA BACLOFEN
18220 A II 3/30/2005 MYLAN LABORATORIES LTD BACLOFEN USP
20885 A II 9/25/2007 EXCELLA GMBH AND CO KG R-BACLOFEN
22881 A II 6/22/2009 SUMITOMO CHEMICAL CO LTD R BACLOFEN
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Queensland Health
McKesson
Accenture
Moodys
Federal Trade Commission
Covington

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