Application 202516
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;40MG | No | No |
| 002 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 10MG BASE;40MG | No | No |
| 003 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;80MG | No | No |
| 004 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 10MG BASE;80MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1075 | Telmisartan and Amlodipine | telmisartan and amlodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1076 | Telmisartan and Amlodipine | telmisartan and amlodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1077 | Telmisartan and Amlodipine | telmisartan and amlodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1078 | Telmisartan and Amlodipine | telmisartan and amlodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |