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FDA NDA · NDA022152

STAVZOR

Sponsor: BIONPHARMA

APPLICATION
NDA022152
TYPE
NDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2026-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

STAVZOR · ReferenceDiscontinued
VALPROIC ACID 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED RELEASE · ORAL
STAVZOR · ReferenceDiscontinued
VALPROIC ACID 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED RELEASE · ORAL
STAVZOR · ReferenceDiscontinued
VALPROIC ACID 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2026-03-31Labeling · Supplement 10 · standard — Letter ↗AP
2021-11-30Labeling · Supplement 9 · standard — Label ↗AP
2019-12-26Labeling · Supplement 8 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 7 · standard — Letter ↗AP
2014-03-07Labeling · Supplement 6 · standard — Label ↗AP
2013-06-14Labeling · Supplement 5 · standard — Letter ↗AP
2013-02-26Labeling · Supplement 4 · standard — Label ↗AP
2013-02-26Labeling · Supplement 3 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 2 · 901 required — Label ↗AP
2009-02-04Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2008-07-29Type 3 - New Dosage Form · Original · standard — Label ↗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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