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Last Updated: December 22, 2024

Drug Master Files for: estradiol valerate


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estradiol valerate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10115 I II 3/3/1993 PHARMACO LIFE SCIENCE RESEARCH METHOD VALIDATION REPORT, METHOD 29, GC/MS ANALYSIS OF UNCONJUGATED ESTRONE AND 17B-ESTRADIOL IN HUMAN PLASMA
10536 I II 10/18/1993 PHARMACIA AND UPJOHN SUB PFIZER INC ESTRADIOL
10542 I II 10/25/1993 CYGNUS INC ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM
10591 I II 11/24/1993 CYGNUS INC ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM
10651 I II 12/9/1993 CYGNUS INC ESTRADIOL TRANSDERMAL DELIVERY SYSTEM (E2 III TDS)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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