Application 214053
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 120MG;EQ 15MG BASE | No | No |
| 002 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 200MG;EQ 25MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78836 | ORIG | 2024-06-20 |