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Last Updated: December 12, 2019

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Drug Master Files for: PHENDIMETRAZINE TARTRATE

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PHENDIMETRAZINE TARTRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
2093 I II 4/6/1973 DELMAR CHEMICALS INC PHENDIMETRAZINE BITARTRATE (BULK POWDER)
2097 I II 4/25/1973 GANES CHEMICALS INC PENNSVILLE DIV PHENDIMETRAZINE BITARTRATE BULK
2140 A II 8/7/1973 OLON SPA PHENDIMETRAZINE TARTRATE
2208 I 12/18/1973 CYCLO CHEM DIV TRAVENOL LABS INC PHENDIMETRAZINE TARTRATE
3135 I II 12/15/1977 KV PHARMACEUTICAL CO PHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG.
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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