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Last Updated: November 21, 2024

Drug Master Files for: diazepam


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diazepam Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1478 A II 2/3/1970 CAMBREX PROFARMACO MILANO SRL DIAZEPAM
17691 I III 9/20/2004 PHILLIPS PLASTICS CORP DIASTAT(R) (DIAZEPAM RECTAL GEL) RECTAL DELIVERY SYSTEM
21860 A II 7/24/2008 CENTAUR PHARMACEUTICALS PRIVATE LTD DIAZEPAM USP
2582 I II 1/6/1976 DELMAR CHEMICALS INC DIAZEPAM USP BULK
3164 A II 2/28/1978 FIS FABBRICA ITALIANA SINTETICI SPA DIAZEPAM
3523 I II 2/22/1979 POLFA TARCHOMIN DIAZEPAM, BULK
6071 I II 10/7/1985 GEDEON RICHTER LTD DIAZEPAM USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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