Details for New Drug Application (NDA): 203730
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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 203730
Tradename: | DIVALPROEX SODIUM |
Applicant: | Amneal Pharms |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203730
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 203730
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 203730 | ANDA | Major Pharmaceuticals | 0904-7181 | 0904-7181-45 | 80 BLISTER PACK in 1 CARTON (0904-7181-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 203730 | ANDA | Major Pharmaceuticals | 0904-7181 | 0904-7181-61 | 100 BLISTER PACK in 1 CARTON (0904-7181-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
Approval Date: | May 29, 2015 | 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: | May 29, 2015 | TE: | AB | RLD: | No |
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