Drug Master Files for: COBICISTAT
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COBICISTAT Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25188 | A | II | 10/24/2011 | GILEAD SCIENCES INC | COBICISTAT ON SILICON DIOXIDE |
| 28438 | A | II | 8/8/2014 | MYLAN LABORATORIES LTD | COBICISTAT ON SILICON DIOXIDE |
| 29615 | A | II | 9/2/2015 | MYLAN LABORATORIES LTD | COBICISTAT ON SILICON DIOXIDE (PROCESS-II) |
| 30287 | A | II | 9/7/2016 | HONOUR LAB LTD | COBICISTAT ON COLLOIDAL SILICON DIOXIDE |
| 30650 | A | II | 7/2/2016 | MSN LIFE SCIENCES PRIVATE LTD | COBICISTAT ON SILICON DIOXIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
