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Application 078500
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 2.5MG BASE | No | No |
| 002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55154-3392 | Amlodipine Besylate | Amlodipine Besylate | Cardinal Health | ANDA | Current |
| 55648-421 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-422 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-423 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | WOCKHARDT LIMITED | ANDA | Current |
| 64679-421 | Amlodipine Besylate | Amlodipine Besylate | Wockhardt USA LLC. | ANDA | Current |
| 64679-422 | Amlodipine Besylate | Amlodipine Besylate | Wockhardt USA LLC. | ANDA | Current |
| 64679-423 | Amlodipine Besylate | Amlodipine Besylate | Wockhardt USA LLC. | ANDA | Current |