Drug Master Files for: DOLUTEGRAVIR SODIUM
✉ Email this page to a colleague
DOLUTEGRAVIR SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 28721 | A | II | 10/14/2014 | AUROBINDO PHARMA LTD | DOLUTEGRAVIR SODIUM |
| 30011 | A | II | 11/26/2015 | MYLAN LABORATORIES LTD | DOLUTEGRAVIR SODIUM |
| 30055 | A | II | 3/17/2016 | CIPLA LTD | DOLUTEGRAVIR SODIUM |
| 30365 | A | II | 2/3/2016 | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD | DOLUTEGRAVIR SODIUM |
| 30544 | A | II | 5/20/2016 | HETERO LABS LTD | DOLUTEGRAVIR SODIUM |
| 30933 | A | II | 12/19/2016 | LEK PHARMACEUTICALS DD | DOLUTEGRAVIR SODIUM |
| 30935 | A | II | 9/28/2016 | LAURUS LABS LTD | DOLUTEGRAVIR SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
