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Last Updated: March 28, 2024

Drug Master Files for: bromocriptine mesylate


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bromocriptine mesylate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10679 I II 12/15/1993 CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD BROMOCRIPTINE MESYLATE
11973 I II 5/6/1996 GALENA AS BROMOCRIPTINE MESYLATE
14768 A II 3/3/2000 TEVA PHARMACEUTICAL INDUSTRIES LTD BROMOCRIPTINE MESYLATE
6737 I II 12/16/1986 GEDEON RICHTER LTD BROMOCRIPTINE MESYLATE USP
6827 A II 2/13/1987 LEK PHARMACEUTICALS DD BROMOCRIPTINE MESYLATE USP
6955 A II 5/11/1987 EUTICALS SPA BROMOCRIPTINE MESYLATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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