Application 202713
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-458 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-458 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-459 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-459 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-460 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-460 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-461 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-461 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-205 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-205 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-205 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-205 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-205 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-205 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-206 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-207 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-207 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-207 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-207 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-207 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-207 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-208 | Amlodipine and Valsartan | Amlodipine and Valsartan | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10095 | ORIG | 2015-04-08 |