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Last Updated: August 7, 2020

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Drug Master Files for: ETHIONAMIDE

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ETHIONAMIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23640 A II 3/17/2010 ORGAPHARM ETHIONAMIDE DRUG SUBSTANCE
435 I II 6/22/1961 RHODIA INC ETHIONAMIDE
5604 I II 11/7/1984 GEDEON RICHTER LTD ETHIONAMIDE
8010 I II 4/3/1989 RHONE POULENC RORER PHARMACEUTICALS INC ETHIONAMIDE SUPPOSITORIES, 500 MG, THERAPLIX SA, PARIS, FR
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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