Drug Master Files for: ELVITEGRAVIR
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ELVITEGRAVIR Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25187 | A | II | 10/21/2011 | GILEAD SCIENCES INC | ELVITEGRAVIR |
| 27727 | A | II | 12/27/2013 | MYLAN LABORATORIES LTD | ELVITEGRAVIR |
| 29558 | A | II | 8/28/2015 | MYLAN LABORATORIES LTD | ELVITEGRAVIR (PROCESS-II) |
| 30772 | A | II | 8/30/2016 | MSN LIFE SCIENCES PRIVATE LTD | ELVITEGRAVIR (FORM-II) |
| 31090 | A | II | 12/27/2016 | MSN LIFE SCIENCES PRIVATE LTD | ELVITEGRAVIR (FORM-I) |
| 32456 | A | II | 12/20/2017 | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD | ELVITEGRAVIR |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
