← FDA DRUG APPROVALS

FDA NDA · NDA021168

DEPAKOTE ER

divalproex sodium

Sponsor: ABBVIE

APPLICATION
NDA021168
TYPE
NDA
ORIGINAL APPROVAL
2000-08-04
LATEST ACTION
2026-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DEPAKOTE ER · ReferencePrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DEPAKOTE ER · ReferencePrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-03-31Labeling · Supplement 52 · standard — Letter ↗AP
2025-05-01Labeling · Supplement 49 · standard — Letter ↗AP
2025-01-23Labeling · Supplement 48 · standard — Label ↗AP
2024-03-18Labeling · Supplement 46 · standard — Letter ↗AP
2023-02-24Labeling · Supplement 44 · standard — Letter ↗AP
2021-11-30Labeling · Supplement 43 · standard — Letter ↗AP
2021-02-10Labeling · Supplement 42 · standard — Letter ↗AP
2020-05-19Labeling · Supplement 41 · standard — Letter ↗AP
2019-11-22Labeling · Supplement 40 · standard — Letter ↗AP
2019-02-21Labeling · Supplement 39 · standard — Letter ↗AP
2018-03-06Labeling · Supplement 38 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 37 · standard — Letter ↗AP
2017-03-06Labeling · Supplement 36 · standard — Label ↗AP
2016-11-02Labeling · Supplement 35 · standard — Letter ↗AP
2016-05-12Manufacturing (CMC) · Supplement 34 · standardAP
2016-02-18Labeling · Supplement 33 · standard — Label ↗AP
2015-09-23Labeling · Supplement 32 · standard — Label ↗AP
2015-03-20Labeling · Supplement 30 · standard — Letter ↗AP
2015-03-13Labeling · Supplement 31 · standard — Label ↗AP
2015-01-07Labeling · Supplement 27 · standard — Label ↗AP
2014-11-20Labeling · Supplement 26 · standard — Label ↗AP
2014-08-20Labeling · Supplement 29 · standard — Label ↗AP
2014-06-19Labeling · Supplement 19 · standard — Label ↗AP
2014-06-09Labeling · Supplement 28 · standard — Label ↗AP
2013-07-31Labeling · Supplement 24 · standard — Letter ↗AP
2013-06-14Labeling · Supplement 25 · standard — Label ↗AP
2013-02-27Labeling · Supplement 23 · standard — Label ↗AP
2011-10-07Labeling · Supplement 17 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 16 · standard — Label ↗AP
2011-10-07Labeling · Supplement 22 · unknown — Label ↗AP
2011-10-07Labeling · Supplement 20 · unknown — Letter ↗AP
2009-04-23Labeling · Supplement 18 · 901 required — Label ↗AP
2008-03-24Efficacy · Supplement 15 · priority — Label ↗AP
2006-10-13Labeling · Supplement 14 · standard — Letter ↗AP
2006-01-11Labeling · Supplement 9 · standard — Label ↗AP
2005-12-06Efficacy · Supplement 12 · standard — Letter ↗AP
2003-08-14Efficacy · Supplement 7 · priority — Letter ↗AP
2003-04-20Manufacturing (CMC) · Supplement 8 · standardAP
2002-12-20Labeling · Supplement 4 · standard — Review ↗AP
2002-12-12Labeling · Supplement 3 · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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