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Last Updated: November 23, 2024

Drug Master Files for: Bristol


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Bristol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10126 I II 6/26/1987 BRISTOL MYERS SQUIBB CO CRUDE AMPHOTERICIN SLURRY
10132 I II 6/20/1989 BRISTOL MYERS SQUIBB CO 7-AMINO CEPHALOSPORANIC ACID (7-ACA)
10133 I II 2/2/1982 BRISTOL MYERS SQUIBB CO PIPERACILLIN MONOHYDRATE
10139 I II 6/10/1968 BRISTOL MYERS SQUIBB CO 6-APA
10155 I II 8/27/1974 BRISTOL MYERS SQUIBB CO 7-ADCA
1075 I 8/7/1967 BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO NEOCARZINOSTATIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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