Application 205761
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-721 | Rabeprazole Sodium | Rabeprazole Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-721 | Rabeprazole Sodium | Rabeprazole Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-721 | Rabeprazole Sodium | Rabeprazole Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-721 | Rabeprazole Sodium | Rabeprazole Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 68788-7657 | Rabeprazole Sodium | Rabeprazole Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7657 | Rabeprazole Sodium | Rabeprazole Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7657 | Rabeprazole Sodium | Rabeprazole Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2860 | Rabeprazole Sodium | Rabeprazole Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2860 | Rabeprazole Sodium | Rabeprazole Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2860 | Rabeprazole Sodium | Rabeprazole Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2860 | Rabeprazole Sodium | Rabeprazole Sodium | REMEDYREPACK INC. | ANDA | Current |
| 71335-1558 | Rabeprazole Sodium | Rabeprazole Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1558 | Rabeprazole Sodium | Rabeprazole Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1558 | Rabeprazole Sodium | Rabeprazole Sodium | Bryant Ranch Prepack | ANDA | Current |
| 72189-142 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 72189-142 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 72189-142 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 72189-142 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 72189-142 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 76420-107 | Rabeprazole Sodium | Rabeprazole Sodium | Asclemed USA, Inc. | ANDA | Current |