Drug Master Files for: OSELTAMIVIR PHOSPHATE
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OSELTAMIVIR PHOSPHATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21557 | A | II | 5/29/2008 | CIPLA LTD | OSELTAMIVIR PHOSPHATE USP |
| 22926 | A | II | 7/8/2009 | SOLARA A PHARMA SCIENCES LTD | OSELTAMIVIR PHOSPHATE |
| 23889 | A | II | 6/15/2010 | MSN PHARMACHEM PRIVATE LTD | OSELTAMIVIR PHOSPHATE [ROUTE CODE - OT] |
| 27533 | A | II | 9/29/2013 | MACLEODS PHARMACEUTICALS LTD | OSELTAMIVIR PHOSPHATE |
| 30012 | A | II | 11/30/2015 | MYLAN LABORATORIES LTD | OSELTAMIVIR PHOSPHATE USP |
| 30253 | A | II | 4/13/2016 | LUPIN LTD | OSELTAMIVIR PHOSPHATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
