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Last Updated: November 21, 2024

Drug Master Files for: Pfizer Inc


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Pfizer Inc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10447 I II 8/26/1993 PHARMACIA AND UPJOHN SUB PFIZER INC HYDROCORTISONE BUTYRATE
10536 I II 10/18/1993 PHARMACIA AND UPJOHN SUB PFIZER INC ESTRADIOL
11848 A II 2/8/1996 PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC BETAMETHYL EPOXIDE
12127 A II 9/11/1996 PFIZER INC ALPHAMETHYL EPOXIDE
124 I II 7/23/1953 PFIZER INC NEOMYCIN SULFATE CAPS (THIS D CHANGED TO NDA 9-579)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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