Drug Master Files for: tenofovir alafenamide fumarate
✉ Email this page to a colleague
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) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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