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Generated: January 19, 2019

DrugPatentWatch Database Preview

Drug Master Files for: hydroxyprogesterone

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hydroxyprogesterone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17113 A II 1/21/2004 ASPEN OSS BV HYDROXYPROGESTERONE CAPROATE
2856 I II 2/16/1977 UPJOHN CO HYDROXYPROGESTERONE CAPROATE
28958 A II 2/6/2015 SUN PHARMACEUTICAL INDUSTRIES LTD HYDROXYPROGESTERONE CAPROATE USP
29030 A II 1/20/2015 SYMBIOTEC PHARMALAB PRIVATE LTD 17-a HYDROXYPROGESTERONE (INTERMEDIATE)
2993 I II 7/18/1977 DIOSYNTH BV HYDROXYPROGESTERONE CAPROATE
30747 A II 7/19/2016 SYMBIOTEC PHARMALAB PRIVATE LTD HYDROXYPROGESTERONE CAPROATE USP
31337 A II 1/18/2017 STEROID SPA HYDROXYPROGESTERONE CAPROATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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