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 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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