Skip to contentApplication 076719
- Type
- ANDA
- Sponsor
- APOTEX
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 |
|---|
| 63629-3678 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |