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Valproic

These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES . VALPROIC ACID Capsule s , for oral use. Initial U.S. Approval: 1978

Approved
Approval ID

cef3e335-5891-412f-89c4-79fcd2f145b7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 1, 2021

Manufacturers
FDA

Actavis Pharma, Inc.

DUNS: 119723554

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Valproic Acid

PRODUCT DETAILS

NDC Product Code0591-4012
Application NumberANDA073229
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 1, 2021
Generic NameValproic Acid

INGREDIENTS (5)

VALPROIC ACIDActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
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Valproic - FDA Approval | MedPath