Details for New Drug Application (NDA): 213181
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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 213181
Tradename: | DIVALPROEX SODIUM |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213181
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 213181
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 213181 | ANDA | Ajanta Pharma USA Inc. | 27241-115 | 27241-115-01 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-01) |
DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 213181 | ANDA | Ajanta Pharma USA Inc. | 27241-115 | 27241-115-05 | 500 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 125MG VALPROIC ACID | ||||
Approval Date: | Mar 2, 2020 | TE: | AB | RLD: | No |
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