Details for New Drug Application (NDA): 078182
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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 078182
Tradename: | DIVALPROEX SODIUM |
Applicant: | Upsher Smith Labs |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078182
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078182
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078182 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8326 | 0615-8326-39 | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8326-39) |
DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078182 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8327 | 0615-8327-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8327-30) / 5 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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