Drug Master Files for: SUNITINIB MALATE
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SUNITINIB MALATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23414 | A | II | 12/29/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SUNITINIB MALATE |
| 24509 | A | II | 12/30/2010 | MYLAN LABORATORIES LTD | SUNITINIB MALATE |
| 26464 | I | II | 9/18/2012 | SICHUAN XIELI PHARMACEUTICAL CO LTD | SUNITINIB MALATE |
| 29014 | A | II | 3/4/2015 | RELIANCE LIFE SCIENCES PVT LTD | SUNITINIB MALATE |
| 30559 | A | II | 6/3/2016 | MEDICHEM MANUFACTURING MALTA LTD | SUNITINIB MALATE |
| 31320 | A | II | 2/20/2017 | HIKMA PHARMACEUTICALS PLC | SUNITINIB L-MALATE |
| 33085 | A | II | 9/19/2018 | SHILPA MEDICARE LTD | SUNITINIB MALATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
