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Last Updated: November 16, 2024

Drug Master Files for: BENZOYL PEROXIDE


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BENZOYL PEROXIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14834 A II 4/12/2000 CORDEN PHARMA BERGAMO SPA BENZOYL PEROXIDE, HYDROUS
15218 A II 12/27/2000 CAMBREX KARLSKOGA AB HYDROUS BENZOYL PEROXIDE
15345 I II 3/16/2001 AKZO NOBEL POLYMER CHEMICALS LLC PERKADOX API (BENZOYL PEROXIDE)
15748 A II 12/3/2001 NORAC PHARMA HYDROUS BENZOYL PEROXIDE, 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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