Application 211148
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | TABLET; ORAL | 10MG | No | No |
| 002 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | TABLET; ORAL | 15MG | No | No |
| 003 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | TABLET; ORAL | 25MG | No | No |
| 004 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | TABLET; ORAL | 120MG | No | No |
| 005 | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | EMTRICITABINE, TENOFOVIR ALAFENAMIDE | TABLET; ORAL | 200MG | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.