Application 205234
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-184 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-184 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-185 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-185 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-186 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-186 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-187 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-187 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Alembic Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 46029 | ORIG | 2016-12-06 |