Details for New Drug Application (NDA): 078597
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NDA 078597 describes DIVALPROEX SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Dr Reddys Labs Ltd, Mankind Pharma, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invatech, Lupin, Mylan, Orbion Pharms, Ph Health, Pharmobedient, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Sciegen Pharms, Unichem, and Yichang Humanwell, and is included in thirty-eight NDAs. It is available from forty-two suppliers. Additional details are available on the DIVALPROEX SODIUM profile page.
The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078597
| Tradename: | DIVALPROEX SODIUM |
| Applicant: | Sun Pharm Inds |
| Ingredient: | divalproex sodium |
| Patents: | 0 |
Pharmacology for NDA: 078597
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078597
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078597 | ANDA | Major Pharmaceuticals | 0904-6860 | 0904-6860-61 | 100 BLISTER PACK in 1 CARTON (0904-6860-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078597 | ANDA | Major Pharmaceuticals | 0904-6861 | 0904-6861-61 | 100 BLISTER PACK in 1 CARTON (0904-6861-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 125MG VALPROIC ACID | ||||
| Approval Date: | Jul 29, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
| Approval Date: | Jul 29, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
| Approval Date: | Jul 29, 2008 | TE: | AB | RLD: | No | ||||
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