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Last Updated: November 22, 2024

Drug Master Files for: ETHINYL ESTRADIOL


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ETHINYL ESTRADIOL Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10591 I II 11/24/1993 CYGNUS INC ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM
11922 I II 4/15/1996 RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE 17-DEACETYLNORGESTIMATE/ETHINYL ESTRADIOL TRANSDERMAL CONTRACEPTIVE SYSTEM
1323 I II 2/6/1969 PHYTOGEN PRODUCTS INC 19-NOR-17-ALPHA-ETHINYLTESTERONE
1431 I II 9/16/1969 ORGANON INC ETHINYL ESTRADIOL
14960 A II 7/25/2000 BAYER AG ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-CLATHRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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