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Last Updated: December 6, 2019

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Drug Master Files for: DIETHYLPROPION HYDROCHLORIDE

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DIETHYLPROPION HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1087 I 10/18/1967 RICHARDSON-MERRELL INC DIETHYLPROPION HCL
1088 I 10/17/1967 RICHARDSON-MERRELL INC DIETHYLPROPION HCL WITH TARTARIC ACID
2142 I II 8/21/1973 GYMA LABORATORIES AMERICA INC DIETHYLPROPIONE HCL
2566 I II 11/25/1975 GANES CHEMICALS INC PENNSVILLE DIV DIETHYLPROPION HYDROCHLORIDE
2738 A II 8/2/1976 OLON SPA DIETHYLPROPION HCL
2804 I 12/1/1976 SIEGFRIED AG DIETHYLPROPION HCL
2873 I 3/4/1977 TROPONWERKE GMBH CO KG AMFEPRAMON HCL (FORMERLY DIETHYLPROPION)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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