← FDA DRUG APPROVALS

FDA NDA · NDA018081

DEPAKENE

Sponsor: ABBVIE

APPLICATION
NDA018081
TYPE
NDA
ORIGINAL APPROVAL
1978-02-28
LATEST ACTION
2020-05-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DEPAKENE · ReferenceDiscontinued
VALPROIC ACID 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2020-05-19Labeling · Supplement 71 · standard — Label ↗AP
2019-11-22Labeling · Supplement 70 · standard — Letter ↗AP
2019-02-21Labeling · Supplement 69 · standard — Letter ↗AP
2018-03-06Labeling · Supplement 68 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 67 · standard — Letter ↗AP
2017-03-06Labeling · Supplement 66 · standard — Label ↗AP
2016-11-02Labeling · Supplement 65 · standard — Letter ↗AP
2016-02-18Labeling · Supplement 64 · standard — Letter ↗AP
2015-09-23Labeling · Supplement 63 · standard — Letter ↗AP
2015-03-13Labeling · Supplement 62 · standard — Letter ↗AP
2015-01-07Labeling · Supplement 59 · standard — Label ↗AP
2014-11-20Labeling · Supplement 58 · standard — Label ↗AP
2014-08-20Labeling · Supplement 61 · standard — Letter ↗AP
2014-06-19Labeling · Supplement 49 · standard — Label ↗AP
2014-06-09Labeling · Supplement 60 · standard — Label ↗AP
2013-07-31Labeling · Supplement 56 · standard — Label ↗AP
2013-06-14Labeling · Supplement 57 · standard — Label ↗AP
2013-02-27Labeling · Supplement 54 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 48 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 46 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 52 · unknown — Letter ↗AP
2011-10-07Labeling · Supplement 50 · unknown — Label ↗AP
2009-04-23Labeling · Supplement 47 · 901 required — Letter ↗AP
2006-10-13Labeling · Supplement 44 · standard — Letter ↗AP
2006-01-11Labeling · Supplement 42 · standard — Letter ↗AP
2002-12-12Labeling · Supplement 38 · standard — Letter ↗AP
2000-12-20Manufacturing (CMC) · Supplement 35 · priorityAP
2000-06-20Manufacturing (CMC) · Supplement 34 · priorityAP
2000-06-20Manufacturing (CMC) · Supplement 36 · priorityAP
2000-06-19Labeling · Supplement 32 · standardAP
2000-05-16Labeling · Supplement 29 · standardAP
1999-12-06Manufacturing (CMC) · Supplement 33 · priorityAP
1998-09-22Manufacturing (CMC) · Supplement 31 · priorityAP
1998-05-08Manufacturing (CMC) · Supplement 30 · priorityAP
1996-12-02Manufacturing (CMC) · Supplement 28 · priorityAP
1995-03-23Manufacturing (CMC) · Supplement 25 · priorityAP
1989-03-21Manufacturing (CMC) · Supplement 21 · priorityAP
1987-12-02Manufacturing (CMC) · Supplement 20 · priorityAP
1986-08-11Labeling · Supplement 18AP
1986-05-30Labeling · Supplement 17AP
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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