Details for New Drug Application (NDA): 078239
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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 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 | Zydus Lifesciences Limited | 65841-637 | 65841-637-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-637-01) |
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078239 | ANDA | Zydus Lifesciences Limited | 65841-637 | 65841-637-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-637-05) |
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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