Application 203041
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 65862-497 | Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-497 | Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Aurobindo Pharma Limited | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 55944 | ORIG | 2018-10-15 |
| 10147 | ORIG | 2013-04-04 |