Drug Master Files for: deferasirox
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deferasirox Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22369 | A | II | 12/20/2008 | MYLAN LABORATORIES LTD | DEFERASIROX |
| 24209 | A | II | 10/28/2010 | GLENMARK PHARMACEUTICALS LTD | DEFERASIROX |
| 25733 | A | II | 1/26/2012 | NEULAND LABORATORIES LTD | DEFERASIROX |
| 25837 | A | II | 2/21/2012 | MSN LABORATORIES PRIVATE LTD | DEFERASIROX [ROUTE CODE - DR] |
| 25888 | A | II | 3/30/2012 | JUBILANT GENERICS LTD | DEFERASIROX |
| 25964 | A | II | 3/27/2012 | PARABOLIC DRUGS LTD | DEFERASIROX |
| 26003 | I | II | 4/19/2012 | BACHEM SA | DEFERASIROX |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
