Drug Master Files for: APREPITANT
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APREPITANT Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20381 | A | II | 3/28/2007 | GLENMARK PHARMACEUTICALS LTD | APREPITANT USP |
| 21345 | A | II | 2/18/2008 | DR REDDYS LABORATORIES LTD | APREPITANT USP |
| 24829 | A | II | 3/31/2011 | DR REDDYS LABORATORIES LTD | FOSAPREPITANT DIMEGLUMINE |
| 24835 | A | II | 4/7/2011 | MSN PHARMACHEM PRIVATE LTD | APREPITANT USP (ROUTE CODE - AP) |
| 25572 | A | II | 12/12/2011 | HETERO DRUGS LTD | APREPITANT |
| 25614 | A | II | 12/21/2011 | HETERO DRUGS LTD | FOSAPREPITANT DIMEGLUMINE |
| 25682 | A | II | 1/6/2012 | MSN LABORATORIES PRIVATE LTD | FOSAPREPITANT DIMEGLUMINE [ROUTE CODE - FD] |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
