Application 076692
- Type
- ANDA
- Sponsor
- HEBEI CHANGSHAN
Related Records
Application Products
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55111-269 | Amlodipine Besylate | Amlodipine Besylate | Dr Reddy's Laboratories | ANDA | Current |
| 55111-270 | Amlodipine Besylate | Amlodipine Besylate | Dr Reddy's Laboratories | ANDA | Current |
| 55111-271 | Amlodipine Besylate | Amlodipine Besylate | Dr Reddy's Laboratories | ANDA | Current |
| 69117-0051 | Amlodipine Besylate | Amlodipine Besylate | Yiling Pharmaceutical, Inc. | ANDA | Current |
| 69117-0052 | Amlodipine Besylate | Amlodipine Besylate | Yiling Pharmaceutical, Inc. | ANDA | Current |
| 69117-0053 | Amlodipine Besylate | Amlodipine Besylate | Yiling Pharmaceutical, Inc. | ANDA | Current |