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Last Updated: March 28, 2024

Drug Master Files for: cholestyramine


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cholestyramine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21726 I II 3/17/2008 THERMAX LTD CHEMICAL DIV TULSION 412 CHL (CHOLESTYRAMINE RESIN USP)
23171 A II 10/5/2009 ION EXCHANGE INDIA LTD CHOLESTYRAMINE RESIN USP (INDION 454)
27607 A II 8/2/2013 PHAEX POLYMERS PRIVATE LTD CHOLESTYRAMINE RESIN USP AS IN
5673 A II 12/10/1984 DOW FRANCE DUOLITE? AP143/1083 CHOLESTYRAMINE RESIN USP
5759 I II 2/18/1985 DOW CHEMICAL CO CHOLESTYRAMINE USP
61 I II 9/16/1963 ROHM AND HAAS CO RESINS - ION EXCHANGE AMBERLITE IRP 276 (CHOLESTYRAMINE RESIN USP)
6506 I II 7/11/1986 ROHM AND HAAS CO CHOLESTYRAMINE RESIN, USP-AMBERLITE IRP-276
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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