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Last Updated: November 4, 2024

Drug Master Files for: testosterone cypionate


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testosterone cypionate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11826 A II 1/3/1996 ASPEN OSS BV TESTOSTERONE
14540 A II 11/18/1999 ASPEN OSS BV TESTOSTERONE UNDECANOATE
15077 A II 10/2/2000 BAYER AG TESTOSTERONE
16136 I II 9/16/2002 3M PHARMACEUTICALS SBC TESTOSTERONE/ESTRADIOL TRANSDERMAL DELIVERY SYSTEMS CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) AND TOXICOLOGY
16795 A II 8/15/2003 BAYER AG TESTOSTERONE UNDECANOATE
16809 A II 8/15/2003 BAYER AG TESTOSTERONE UNDECANOATE 750 MG I.M.
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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