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Last Updated: December 12, 2019

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Drug Master Files for: ketoprofen

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ketoprofen Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10045 I II 1/13/1993 NORDIC SYNTHESIS AB KETOPROFEN
11099 I II 9/28/1994 SEPRACOR INC (S)-KETOPROFEN
11486 I II 5/12/1995 NAGASE FINE CHEMICALS LTD S-KETOPROFEN
12020 I II 6/25/1996 CHIREX LTD KETOPROFEN
18148 I II 2/21/2005 BIDACHEM SPA KETOPROFEN
19457 A II 5/23/2006 SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL KETOPROFEN
22149 I II 8/15/2008 HUBEI XUNDA PHARMACEUTICAL CO LTD KETOPROFEN
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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