Drug Master Files for: dolasetron mesylate
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dolasetron mesylate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21852 | A | II | 7/31/2008 | ROLABO OUTSOURCING SL | DOLASETRON MESYLATE |
| 24145 | I | II | 9/23/2010 | USV LTD | DOLASETRON MESYLATE USP |
| 24531 | I | II | 1/6/2011 | APOTEX PHARMACHEM INDIA PVT LTD | DOLASETRON MESYLATE MONOHYDRATE USP |
| 24794 | A | II | 3/28/2011 | EMCURE PHARMACEUTICALS LTD | DOLASETRON MESYLATE USP |
| 33211 | A | II | 9/28/2018 | USV PRIVATE LTD | DOLASETRON MESYLATE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
