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Generated: November 16, 2018

DrugPatentWatch Database Preview

Drug Master Files for: pentamidine

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pentamidine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10316 I II 6/25/1993 SIPSY CHIMIE FINE SCA PENTAMIDINE ISETHIONATE
31636 A II 10/11/2017 RELIABLE BIOPHARMACEUTICAL LLC PENTAMIDINE ISETHIONATE USP
5280 I II 4/20/1984 ALDRICH CHEMICAL CO INC PENTAMIDINE ISETHIONATE (PRODUCT W149-5)
6288 I II 12/13/1985 RHONE POULENC RORER INC PENTAMIDINE ISETHIONATE
6447 I II 7/2/1986 MACFARLAN SMITH JOHNSON MATTHEY PLC BUSINESS PENTAMIDINE ISETHIONATE,(BULK)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Boehringer Ingelheim
Chubb
Fish and Richardson
Teva
Covington
Baxter
Argus Health
Deloitte
McKesson

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