Details for New Drug Application (NDA): 078919
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The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078919
Tradename: | DIVALPROEX SODIUM |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078919
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078919
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 078919 | ANDA | AvPAK | 50268-258 | 50268-258-13 | 30 BLISTER PACK in 1 BOX (50268-258-13) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (50268-258-11) |
DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 078919 | ANDA | Cardinal Health 107, LLC | 55154-4759 | 55154-4759-0 | 10 BLISTER PACK in 1 BAG (55154-4759-0) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 125MG VALPROIC ACID | ||||
Approval Date: | Jan 27, 2009 | TE: | AB | RLD: | No |
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