Details for New Drug Application (NDA): 078979
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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 078979
Tradename: | DIVALPROEX SODIUM |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078979
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078979
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 078979 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8237 | 0615-8237-05 | 15 CAPSULE in 1 BLISTER PACK (0615-8237-05) |
DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 078979 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8237 | 0615-8237-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8237-30) / 5 CAPSULE 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 23, 2009 | TE: | AB | RLD: | No |
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