Drug Master Files for: SORAFENIB TOSYLATE
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SORAFENIB TOSYLATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 24578 | I | II | 3/10/2011 | NATCO PHARMA LTD | SORAFENIB TOSYLATE |
| 26460 | I | II | 9/18/2012 | SICHUAN XIELI PHARMACEUTICAL CO LTD | SORAFENIB TOSYLATE |
| 26693 | A | II | 12/21/2012 | NATCO PHARMA LTD | SORAFENIB TOSYLATE |
| 27793 | I | II | 11/20/2013 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | SORAFENIB TOSYLATE (VERSION NO.: 1) |
| 28556 | A | II | 9/23/2014 | RELIANCE LIFE SCIENCES PVT LTD | SORAFENIB TOSYLATE |
| 29340 | A | II | 6/30/2015 | YABAO PHARMACEUTICAL GROUP CO LTD | SORAFENIB TOSYLATE |
| 29941 | A | II | 11/29/2015 | ALEMBIC PHARMACEUTICALS LTD | SORAFENIB TOSYLATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
