Drug Master Files for: APIXABAN
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APIXABAN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 28009 | A | II | 2/26/2014 | MSN LABORATORIES PRIVATE LTD | APIXABAN [ROUTE CODE AX] |
| 29660 | A | II | 9/30/2015 | ALEMBIC PHARMACEUTICALS LTD | APIXABAN |
| 29667 | A | II | 9/2/2015 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | APIXABAN |
| 29707 | A | II | 9/22/2015 | DR REDDYS LABORATORIES LTD | APIXABAN |
| 30060 | A | II | 12/31/2015 | GLENMARK PHARMACEUTICALS LTD | APIXABAN |
| 30336 | A | II | 3/14/2016 | DELMAR CHEMICALS INC | APIXABAN |
| 30440 | A | II | 4/1/2016 | SCINOPHARM TAIWAN LTD | APIXABAN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
