Application 090513
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG;300MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-354 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-354 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-354 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3077 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3077 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3077 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1844 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Bryant Ranch Prepack | ANDA | Current |
| 72189-403 | Truvada | Emtricitabine/TDF | Direct_Rx | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 52553 | ORIG | 2018-02-09 |
| 9271 | ORIG | 2009-04-03 |