Details for New Drug Application (NDA): 078239
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NDA 078239 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 Inc, Unichem, and Yichang Humanwell, and is included in thirty-eight NDAs. It is available from forty-one 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-two 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-two suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078239
| Tradename: | DIVALPROEX SODIUM |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | divalproex sodium |
| Patents: | 0 |
Pharmacology for NDA: 078239
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078239
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078239 | ANDA | Coupler LLC | 67046-1137 | 67046-1137-3 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1137-3) |
| DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078239 | ANDA | BluePoint Laboratories | 68001-105 | 68001-105-00 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-105-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
| Approval Date: | Feb 27, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
| Approval Date: | Aug 4, 2009 | TE: | AB | RLD: | No | ||||
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