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Last Updated: October 11, 2024

Drug Master Files for: CHLORDIAZEPOXIDE HYDROCHLORIDE


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CHLORDIAZEPOXIDE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
2103 I II 5/16/1973 PHENCHEM INDUSTRIES LTD CHLORDIAZEPOXIDE HCL USP (D FORMERLY HELD BY MICRO CHEMICALS LTD)
2395 I II 1/29/1975 DELMAR CHEMICALS LTD CHLORDIAZEPOXIDE HYDROCHLORIDE
25335 A II 9/29/2011 CENTAUR PHARMACEUTICALS PVT LTD CHLORDIAZEPOXIDE USP
2585 I I 12/19/1975 SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP MANUFACTURING, FACILITIES AND CONTROLS (CHLORDIAZEPOXIDE HCL USP)
2672 I II 5/10/1976 PCR INC CHLORDIAZEPOXIDE AND CHLORDIAZEPOXIDE CHL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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