Drug Master Files for: sevelamer hydrochloride
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sevelamer hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14695 | I | II | 2/24/2000 | DOW CHEMICAL CO | SEVELAMER HYDROCHLORIDE |
| 21104 | A | II | 11/29/2007 | SOLARA A PHARMA SCIENCES LTD | SEVELAMER HYDROCHLORIDE |
| 21488 | A | II | 3/31/2008 | LUPIN LTD | SEVELAMER HYDROCHLORIDE |
| 22069 | A | II | 10/8/2008 | EMCURE PHARMACEUTICALS LTD | SEVELAMER HYDROCHLORIDE (PROCESS-I) |
| 22113 | I | II | 11/4/2008 | USV PRIVATE LTD | SEVELAMER HYDROCHLORIDE |
| 22262 | I | II | 12/3/2008 | CHEMO IBERICA SA MADRID | SEVELAMER CARBONATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
