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Generated: November 15, 2018

DrugPatentWatch Database Preview

Drug Master Files for: norgestrel

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norgestrel Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10218 A II 5/4/1993 BAYER OY NORPLANT (LEVONORGESTREL IMPLANTS)
12934 I II 3/20/1998 YANGZHOU PHARMACEUTICAL FACTORY LEVONORGESTREL USP 23
12994 I II 5/18/1998 HUBEI PHARMACEUTICAL FACTORY LEVONORGESTREL, USP
14288 I II 7/12/1999 HOECHST MARION ROUSSEL LEVONORGESTREL
14923 A II 6/16/2000 3M DRUG DELIVERY SYSTEMS CLIMARA PRO(R) ESTRADIOL/LEVONORGESTREL TRANSDERMAL DELIVERY SYSTEM
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Teva
Deloitte
AstraZeneca
Johnson and Johnson
Cantor Fitzgerald
Harvard Business School
US Department of Justice

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