Application 074255
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NADOLOL | NADOLOL | TABLET;ORAL | 80MG | No | No |
| 002 | NADOLOL | NADOLOL | TABLET;ORAL | 120MG | No | No |
| 003 | NADOLOL | NADOLOL | TABLET;ORAL | 160MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-4237 | Nadolol | Nadolol | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 23155-732 | Nadolol | Nadolol | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-732 | Nadolol | Nadolol | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 71335-1972 | Nadolol | Nadolol | Bryant Ranch Prepack | ANDA | Current |