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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Deloitte
Dow
Accenture
Cerilliant
Express Scripts
Johnson and Johnson
Teva
Mallinckrodt

Generated: July 19, 2018

DrugPatentWatch Database Preview

Drug Master Files for: flutamide

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flutamide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
4144 I II 4/16/1981 GANES CHEMICALS INC PENNSVILLE DIV FLUTAMIDE
8679 I II 8/2/1990 FINE CHEMICALS CORP FLUTAMIDE
10497 I II 9/24/1993 GEDEON RICHTER USA INC FLUTAMIDE
11522 A II 5/23/1995 FERMION OY FLUTAMIDE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Healthtrust
Covington
Dow
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
Cerilliant
Cantor Fitzgerald
Daiichi Sankyo

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