Application 090554
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 125MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
| 003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-2795 | Divalproex Sodium | Divalproex Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-2795 | Divalproex Sodium | Divalproex Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3616 | Divalproex Sodium | Divalproex Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-5842 | Divalproex Sodium | Divalproex Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-5843 | Divalproex Sodium | Divalproex Sodium | A-S Medication Solutions | ANDA | Current |
| 53808-1065 | Divalproex Sodium | Divalproex Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4679 | Divalproex Sodium | Divalproex Sodium | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4679 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-4679 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-4679 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-7145 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-7145 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-7145 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-7145 | Divalproex Sodium | Divalproex Sodium | Cardinal Health 107, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-047 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-048 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 57237-106 | Divalproex Sodium | Divalproex Sodium | Rising Health, LLC | ANDA | Current |
| 60687-211 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 60687-211 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 60687-211 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 60687-211 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-402 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-403 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-959 | Divalproex Sodium | Divalproex Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 67046-141 | Divalproex Sodium | Divalproex Sodium | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-2717 | Divalproex Sodium | Divalproex Sodium | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68084-776 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-776 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-776 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-776 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-782 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-782 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-782 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68084-782 | Divalproex Sodium | Divalproex Sodium | American Health Packaging | ANDA | Current |
| 68788-8145 | Divalproex Sodium | Divalproex Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |