Application 213541
- Type
- ANDA
- Sponsor
- LAURUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 600MG;200MG;300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42385-915 | Efavirenz, emtricitabine and tenofovir disoproxil fumarate | Efavirenz, emtricitabine and tenofovir disoproxil fumarate | Laurus Labs Limited | ANDA | Current |