Application 090958
- Type
- ANDA
- Sponsor
- CIPLA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMTRICITABINE; 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 |
|---|---|---|---|---|---|
| 69097-209 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-741 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 76282-677 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Exelan Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31507 | ORIG | 2014-02-27 |