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Application 074477
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 12.5MG | No | No |
| 002 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 25MG | No | No |
| 003 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 50MG | No | No |
| 004 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-8052 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8052 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8061 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8061 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8075 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8075 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8080 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 0781-8080 | Captopril | Captopril | SANDOZ INC. | ANDA | Current |
| 50090-4296 | Captopril | Captopril | A-S Medication Solutions | ANDA | Current |
| 50090-4296 | Captopril | Captopril | A-S Medication Solutions | ANDA | Current |
| 63629-8727 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8727 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8728 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8728 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8729 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8729 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8730 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 63629-8730 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 71335-0826 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 71335-0826 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 71335-0826 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |