Application 077100
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-7848 | Divalproex Sodium | Divalproex Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7849 | Divalproex Sodium | Divalproex Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7850 | Divalproex Sodium | Divalproex Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 65841-634 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-634 | Divalproex Sodium | Divalproex Sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-634 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-634 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-635 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-635 | Divalproex Sodium | Divalproex Sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-635 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-635 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-636 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-636 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-636 | Divalproex Sodium | Divalproex Sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-636 | Divalproex Sodium | Divalproex Sodium | Cadila Healthcare Limited | ANDA | Current |
| 67046-137 | Divalproex Sodium | Divalproex Sodium | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-138 | Divalproex Sodium | Divalproex Sodium | Contract Pharmacy Services-PA | ANDA | Current |
| 68382-031 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (US | ANDA | Current |
| 68382-031 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-031 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-031 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-032 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (US | ANDA | Current |
| 68382-032 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-032 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-032 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-033 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (US | ANDA | Current |
| 68382-033 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-033 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-033 | Divalproex Sodium | Divalproex Sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |