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Last Updated: November 15, 2024

Drug Master Files for: TROSPIUM CHLORIDE


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TROSPIUM CHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14967 I II 7/20/2000 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG TROSPIUM CHLORIDE
18544 A II 7/29/2005 HELSINN ADVANCED SYNTHESIS SA TROSPIUM CHLORIDE
21171 I II 10/10/2007 INTERPHARMA PRAHA AS Trospium Chloride
21400 A II 3/4/2008 SIEGFRIED EVIONNAZ SA TROSPIUM 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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