Drug Master Files for: COLESEVELAM HYDROCHLORIDE
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COLESEVELAM HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22870 | A | II | 6/16/2009 | FORMOSA LABORATORIES INC | COLESEVELAM HYDROCHLORIDE |
| 23333 | A | II | 4/6/2010 | LUPIN LTD | COLESEVELAM HYDROCHLORIDE |
| 23378 | A | II | 12/16/2009 | SOLARA A PHARMA SCIENCES LTD | COLESEVELAM HYDROCHLORIDE |
| 25696 | I | II | 3/20/2012 | USV LTD | COLESEVELAM HYDROCHLORIDE |
| 26813 | I | II | 2/5/2013 | IND SWIFT LABORATORIES LTD | COLESEVELAM HYDROCHLORIDE |
| 26934 | A | II | 3/31/2013 | EMCURE PHARMACEUTICALS LTD | COLESEVELAM HYDROCHLORIDE |
| 27492 | I | II | 9/27/2013 | CTX LIFE SCIENCES PVT LTD | COLESEVELAM HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
