| NDC Code | 0378-1078-93 |
| Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (0378-1078-93) |
| Product NDC | 0378-1078 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Telmisartan And Amlodipine |
| Non-Proprietary Name | Telmisartan And Amlodipine |
| Dosage Form | TABLET |
| Usage | ORAL |
| Start Marketing Date | 20140919 |
| Marketing Category Name | ANDA |
| Application Number | ANDA202516 |
| Manufacturer | Mylan Pharmaceuticals Inc. |
| Substance Name | AMLODIPINE BESYLATE; TELMISARTAN |
| Strength | 10; 80 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS] |