Drug Master Files for: TENOFOVIR ALAFENAMIDE FUMARATE
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TENOFOVIR ALAFENAMIDE FUMARATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20003 | A | II | 11/29/2006 | CIPLA LTD | TENOFOVIR DISOPROXIL FUMARATE |
| 20108 | A | II | 1/3/2007 | MYLAN LABORATORIES LTD | TENOFOVIR DISOPROXIL FUMARATE |
| 21096 | A | II | 11/23/2007 | AUROBINDO PHARMA LTD | Tenofovir Disoproxil Fumarate (Non-Sterile Drug Substance) |
| 21098 | I | II | 12/3/2007 | SUN PHARMACEUTICAL INDUSTRIES LTD | TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE |
| 21540 | A | II | 4/17/2008 | HETERO LABS LTD | TENOFOVIR DISOPROXIL FUMARATE |
| 22623 | I | II | 3/16/2009 | EMCURE PHARMACEUTICALS LTD | TENOFOVIR DISOPROXIL FUMARATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
