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Last Updated: December 22, 2024

Drug Master Files for: solifenacin succinate


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solifenacin succinate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
22173 A II 11/12/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD SOLIFENACIN SUCCINATE
22263 A II 12/5/2008 DR REDDYS LABORATORIES LTD SOLIFENACIN SUCCINATE
22418 A II 1/16/2009 GLENMARK PHARMACEUTICALS LTD SOLIFENACIN SUCCINATE
23689 I II 4/5/2010 CADILA HEALTHCARE LTD SOLIFENACIN SUCCINATE
23747 A II 4/26/2010 MSN LABORATORIES PRIVATE LTD SOLIFENACIN SUCCINATE [ROUTE CODE - SF]
23965 A II 7/28/2010 UNIMARK REMEDIES LTD SOLIFENACIN SUCCINATE
24044 A II 8/5/2010 ZAKLADY FARMACEUTYCZNE POLPHARMA SA SOLIFENACIN SUCCINATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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