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Last Updated: February 26, 2021

DrugPatentWatch Database Preview

Drug Master Files for: FLUVASTATIN SODIUM

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FLUVASTATIN SODIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17879 I II 12/7/2004 CADILA HEALTHCARE LTD FLUVASTATIN SODIUM
18493 A II 7/7/2005 BIOCON LTD FLUVASTATIN SODIUM AMORPHOUS
18762 A II 9/13/2005 BIOCON LTD FLUVASTATIN SODIUM
18911 A II 10/11/2005 FIS FABBRICA ITALIANA SINTETICI SPA FLUVASTATIN SODIUM HYDRATE USP
19296 A II 3/24/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD FLUVASTATIN SODIUM
20528 I II 5/11/2007 USV LTD FLUVASTATIN SODIUM USP
21509 A II 3/31/2008 LUPIN LTD FLUVASTATIN SODIUM (MICRONIZED) USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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