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Application 212809
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|
| 0904-7105 | Captopril | Captopril | Major Pharmaceuticals | ANDA | Current |
| 0904-7106 | Captopril | Captopril | Major Pharmaceuticals | ANDA | Current |
| 27241-160 | Captopril | Captopril | Ajanta Pharma Limited | ANDA | Current |
| 27241-160 | Captopril | Captopril | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-161 | Captopril | Captopril | Ajanta Pharma Limited | ANDA | Current |
| 27241-161 | Captopril | Captopril | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-162 | Captopril | Captopril | Ajanta Pharma Limited | ANDA | Current |
| 27241-162 | Captopril | Captopril | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-163 | Captopril | Captopril | Ajanta Pharma Limited | ANDA | Current |
| 27241-163 | Captopril | Captopril | Ajanta Pharma USA Inc. | ANDA | Current |
| 70518-3307 | Captopril | Captopril | REMEDYREPACK INC. | ANDA | Current |
| 71335-1918 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |
| 71335-1918 | Captopril | Captopril | Bryant Ranch Prepack | ANDA | Current |