Application 091235
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;160MG | No | No |
| 002 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;160MG | No | No |
| 003 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;320MG | No | No |
| 004 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;320MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7690 | Amlodipine and Valsartan | Amlodipine and Valsartan | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7692 | Amlodipine and Valsartan | Amlodipine and Valsartan | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7693 | Amlodipine and Valsartan | Amlodipine and Valsartan | Teva Pharmaceuticals USA, Inc. | ANDA | Current |