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FDA ANDA · ANDA076539

VALPROATE SODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA076539
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-26
LATEST ACTION
2026-03-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VALPROATE SODIUMPrescription
VALPROATE SODIUM EQ 100MG BASE/ML · INJECTABLE · INJECTION

Approval history

2026-03-31Labeling · Supplement 23 · standardAP
2024-04-04Labeling · Supplement 12 · standardAP
2024-04-04Labeling · Supplement 11 · standardAP
2016-10-11Labeling · Supplement 10 · standardAP
2015-12-22Labeling · Supplement 9 · standardAP
2015-12-22Labeling · Supplement 7 · standardAP
2015-12-22Labeling · Supplement 5 · standardAP
2015-12-22Labeling · Supplement 8 · standardAP
2015-12-22Labeling · Supplement 6 · standardAP
2003-06-26Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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