Application 213361
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 002 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 003 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 90MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-295 | Nifedipine | Nifedipine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-296 | Nifedipine | Nifedipine | Aurobindo Pharma Limited | ANDA | Current |
| 59651-297 | Nifedipine | Nifedipine | Aurobindo Pharma Limited | ANDA | Current |