Drug Master Files for: DASATINIB
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DASATINIB Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23763 | A | II | 4/21/2010 | HUBEI HAOSUN PHARMACEUTICAL CO LTD | DASATINIB |
| 26494 | I | II | 9/25/2012 | SICHUAN XIELI PHARMACEUTICAL CO LTD | DASATINIB |
| 28342 | A | II | 6/19/2014 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | DASATINIB |
| 29505 | A | II | 9/9/2015 | ALP PHARM BEIJING CO LTD | DASATINIB |
| 30165 | A | II | 12/29/2015 | HIKMA PHARMACEUTICALS PLC | DASATINIB MONOHYDRATE |
| 30219 | A | II | 1/30/2016 | MSN LABORATORIES PRIVATE LTD | DASATINIB PROPYLENE GLYCOL [ROUTE CODE DB] |
| 31169 | A | II | 3/30/2017 | RELIANCE LIFE SCIENCES PVT LTD | DASATINIB |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
