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Last Updated: August 3, 2020

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Drug Master Files for: MEDROXYPROGESTERONE ACETATE

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MEDROXYPROGESTERONE ACETATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12695 A II 10/15/1997 FARMABIOS SPA MEDROXYPROGESTERONE ACETATE
12703 A II 10/20/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD MEDROXYPROGESTERONE ACETATE
15223 I II 1/4/2001 STERLING SRL MEDROXYPROGESTERONE ACETATE
19433 A II 5/10/2006 ZHEJIANG XIANJU PHARMACEUTICAL CO LTD MEDROXYPROGESTERONE ACETATE USP, NON-STERILE BULK DRUG SUBSTANCE
1988 I II 8/28/1972 SEARLE NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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