Drug Master Files for: milnacipran hydrochloride
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milnacipran hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11501 | A | II | 5/11/1995 | PIERRE FABRE MEDICAMENT | MILNACIPRAN HYDROCHLORIDE (PROCESS I) |
| 22351 | A | II | 12/22/2008 | PIERRE FABRE MEDICAMENT | LEVOMILNACIPRAN |
| 22741 | I | II | 4/23/2009 | SUN PHARMACEUTICAL INDUSTRIES LTD | MILNACIPRAN HYDROCHLORIDE |
| 24073 | I | II | 6/30/2010 | PIERRE FABRE MEDICAMENT PLANTES AND INDUSTRIE | MILNACIPRAN HYDROCHLORIDE (PROCESS II) |
| 25022 | A | II | 6/27/2011 | GLENMARK PHARMACEUTICALS LTD | MILNACIPRAN HYDROCHLORIDE |
| 25717 | A | II | 2/23/2012 | COSMA SPA | MILNACIPRAN HYDROCHLORIDE |
| 25865 | A | II | 3/30/2012 | DR REDDYS LABORATORIES LTD | MILNACIPRAN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
