Drug Master Files for: EFAVIRENZ
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EFAVIRENZ Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17802 | A | II | 10/23/2004 | AUROBINDO PHARMA LTD | EFAVIRENZ USP |
| 18230 | A | II | 3/30/2005 | MYLAN LABORATORIES LTD | EFAVIRENZ USP |
| 19932 | A | II | 10/30/2006 | AUROBINDO PHARMA LTD | EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE) |
| 20015 | A | II | 12/5/2006 | HETERO LABS LTD | EFAVIRENZ (PROCESS I) |
| 20196 | I | II | 1/16/2007 | EMCURE PHARMACEUTICALS LTD | EFAVIRENZ USP |
| 20560 | I | II | 5/25/2007 | RANBAXY LABORATORIES LTD | EFAVIRENZ |
| 20711 | A | II | 4/24/2008 | CIPLA LTD | EFAVIRENZ USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
