Application 202419
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-484 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 16714-485 | Divalproex sodium | Divalproex sodium | NorthStar Rx LLC | ANDA | Current |
| 50090-4737 | Divalproex sodium | Divalproex sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4737 | Divalproex sodium | Divalproex sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4737 | Divalproex sodium | Divalproex sodium | A-S Medication Solutions | ANDA | Current |
| 50090-6074 | Divalproex sodium | Divalproex sodium | A-S Medication Solutions | ANDA | Current |
| 63629-4698 | Divalproex sodium | Divalproex sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-4698 | Divalproex sodium | Divalproex sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7091 | Divalproex sodium | Divalproex sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7091 | Divalproex sodium | Divalproex sodium | Bryant Ranch Prepack | ANDA | Current |
| 64725-0595 | Divalproex sodium | Divalproex sodium | TYA Pharmaceuticals | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-594 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-595 | Divalproex sodium | Divalproex sodium | Aurobindo Pharma Limited | ANDA | Current |
| 68788-7177 | Divalproex sodium | Divalproex sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7177 | Divalproex sodium | Divalproex sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7177 | Divalproex sodium | Divalproex sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7177 | Divalproex sodium | Divalproex sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7177 | Divalproex sodium | Divalproex sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1781 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1781 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1781 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1781 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1897 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1897 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1897 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1897 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1897 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2003 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |
| 71610-157 | Divalproex sodium | Divalproex sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-205 | Divalproex sodium | Divalproex sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-249 | Divalproex sodium | Divalproex sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-249 | Divalproex sodium | Divalproex sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-249 | Divalproex sodium | Divalproex sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-289 | Divalproex sodium | Divalproex sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |