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Last Updated: February 20, 2020

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Drug Master Files for: BETHANECHOL CHLORIDE


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BETHANECHOL CHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15213 A II 12/20/2000 CORDEN PHARMA BERGAMO SPA BETHANECHOL CHLORIDE
15737 A II 11/21/2001 SIEGFRIED EVIONNAZ SA BETHANECHOL CHLORIDE
15866 A II 2/18/2002 SERATEC SAS BETHANECHOL CHLORIDE USP
16119 A II 8/27/2002 WOCKHARDT LTD BETHANECHOL CHLORIDE USP
2501 I II 7/25/1975 GANES CHEMICALS INC PENNSVILLE DIV BETHANECHOL CHLORIDE
3213 I II 4/12/1978 CONWAY CHEMICAL CO LTD BETHANECHOL CHL N.F.
4348 I II 12/8/1981 GANES CHEMICALS INC PENNSVILLE DIV BETHANECHOL CHLORIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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