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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
