Application 078165
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 3.125MG | No | No |
| 002 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 6.25MG | No | No |
| 003 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 12.5MG | No | No |
| 004 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68788-8177 | CARVEDILOL | CARVEDILOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8231 | CARVEDILOL | CARVEDILOL | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-3524 | CARVEDILOL | CARVEDILOL | REMEDYREPACK INC. | ANDA | Current |
| 71335-2023 | CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-2023 | CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-2026 | CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | ANDA | Current |
| 71335-2033 | CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | ANDA | Current |
| 72888-034 | CARVEDILOL | CARVEDILOL | Advagen Pharma Ltd | ANDA | Current |
| 72888-035 | CARVEDILOL | CARVEDILOL | Advagen Pharma Ltd | ANDA | Current |
| 72888-036 | CARVEDILOL | CARVEDILOL | Advagen Pharma Ltd | ANDA | Current |
| 72888-037 | CARVEDILOL | CARVEDILOL | Advagen Pharma Ltd | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9127 | ORIG | 2007-09-07 |