Application 201806
- Type
- ANDA
- Sponsor
- HETERO LABS UNIT III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET; ORAL | 200MG; 300MG | No | No |
| 002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 100MG;150MG | No | No |
| 003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 133MG;200MG | No | No |
| 004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 167MG;250MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-560 | Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine and tenofovir disoproxil fumarate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-560 | Emtricitabine and tenofovir disoproxil fumarate | Emtricitabine and tenofovir disoproxil fumarate | Camber Pharmaceuticals, Inc. | ANDA | Current |