Drug Master Files for: emtricitabine
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emtricitabine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19566 | A | II | 6/30/2006 | MYLAN LABORATORIES LTD | EMTRICITABINE |
| 19785 | A | II | 9/22/2006 | CIPLA LTD | EMTRICITABINE |
| 20708 | A | II | 7/18/2007 | AUROBINDO PHARMA LTD | EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE |
| 21612 | A | II | 5/9/2008 | HETERO LABS LTD | EMTRICITABINE |
| 21706 | I | II | 6/17/2008 | RANBAXY LABORATORIES LTD | EMTRICITABINE DRUG SUBSTANCE |
| 22944 | A | II | 9/18/2009 | LUPIN LTD | EMTRICITABINE |
| 23184 | I | II | 10/16/2009 | EMCURE PHARMACEUTICALS LTD | EMTRICITABINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
