Application 203417
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | No | No |
| 002 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 003 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-5870 | Felodipine | Felodipine | A-S Medication Solutions | ANDA | Current |
| 57237-108 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-108 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-108 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-109 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-109 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-109 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-110 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-110 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 57237-110 | Felodipine | Felodipine | Rising Health, LLC | ANDA | Current |
| 65862-673 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-673 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-673 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-674 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-674 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-674 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-675 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-675 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-675 | Felodipine | Felodipine | Aurobindo Pharma Limited | ANDA | Current |
| 71335-1318 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1318 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |