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Last Updated: July 31, 2021

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Drug Master Files for: CORTICOTROPIN


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CORTICOTROPIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11078 A II 9/10/1994 BACHEM AMERICAS INC OVINE CORTICOTROPIN RELEASING FACTOR (0CRF)
1780 I II 8/21/1971 FREDERIKSBERG CHEMICAL LABORATORIES LTD CORTICOTROPIN (ACTH)
21473 A II 3/28/2008 POLYPEPTIDE LABORATORIES INC ALPHA-CORTICOTROPIN (1-24) ACETATE
25341 A II 9/28/2011 MALLINCKRODT INC H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION)
278 I II 10/28/1957 ORTHANA KEMISK FABRIK A S CORTICOTROPIN - GEL
4181 I II 6/10/1981 MERCK SHARP AND DOHME BV CORTICOTROPIN
4384 I II 12/17/1981 SALK INSTITUTE CORTICOTROPIN RELEASING FACTOR (CRF)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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