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Last Updated: July 10, 2020

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Drug Master Files for: OXAZEPAM


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OXAZEPAM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18115 I II 2/25/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD OXAZEPAM
22060 A II 9/30/2008 CENTAUR PHARMACEUTICALS PVT LTD OXAZEPAM USP
4438 A II 2/18/1982 CAMBREX PROFARMACO MILANO SRL OXAZEPAM
4939 I II 1/21/1983 SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT OXAZEPAM
5208 A II 1/9/1984 FIS FABBRICA ITALIANA SINTETICI SPA OXAZEPAM
5268 I II 10/20/1983 INDUSTRIA CHIMICA PROFARMACO SPA ACETYL OXIDE (OXAZEPAM INTERMEDIATE)
6445 I II 6/27/1986 WYETH-AYERST LABORATORIES OXAZEPAM
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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