Details for New Drug Application (NDA): 078791
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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 078791
Tradename: | DIVALPROEX SODIUM |
Applicant: | Impax Labs |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078791
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078791
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078791 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-201 | 71610-201-53 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-53) |
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078791 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-201 | 71610-201-60 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
Approval Date: | May 6, 2009 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
Approval Date: | Aug 4, 2009 | TE: | RLD: | No |
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