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FDA NDA · NDA018082

DEPAKENE

Sponsor: ABBVIE

APPLICATION
NDA018082
TYPE
NDA
ORIGINAL APPROVAL
1978-02-28
LATEST ACTION
2020-05-19
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

DEPAKENE · ReferenceDiscontinued
VALPROIC ACID 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2020-05-19Labeling · Supplement 54 · standard — Letter ↗AP
2019-11-22Labeling · Supplement 53 · standard — Letter ↗AP
2019-02-21Labeling · Supplement 52 · standard — Letter ↗AP
2018-03-06Labeling · Supplement 51 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 50 · standard — Letter ↗AP
2017-03-06Labeling · Supplement 49 · standard — Label ↗AP
2016-11-02Labeling · Supplement 48 · standard — Letter ↗AP
2016-02-18Labeling · Supplement 47 · standard — Label ↗AP
2015-09-23Labeling · Supplement 46 · standard — Letter ↗AP
2015-03-13Labeling · Supplement 45 · standard — Label ↗AP
2015-01-07Labeling · Supplement 42 · standard — Letter ↗AP
2014-11-20Labeling · Supplement 41 · standard — Letter ↗AP
2014-08-20Labeling · Supplement 44 · standard — Label ↗AP
2014-06-19Labeling · Supplement 34 · standard — Letter ↗AP
2014-06-09Labeling · Supplement 43 · standard — Label ↗AP
2013-07-31Labeling · Supplement 39 · standard — Letter ↗AP
2013-06-14Labeling · Supplement 40 · standard — Label ↗AP
2013-02-27Labeling · Supplement 38 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 33 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 31 · standard — Label ↗AP
2011-10-07Labeling · Supplement 37 · unknown — Letter ↗AP
2011-10-07Labeling · Supplement 35 · unknown — Letter ↗AP
2009-04-23Labeling · Supplement 32 · 901 required — Letter ↗AP
2006-10-13Labeling · Supplement 27 · standard — Letter ↗AP
2006-01-11Labeling · Supplement 26 · standard — Letter ↗AP
2002-12-12Labeling · Supplement 24 · standard — Letter ↗AP
2000-06-19Labeling · Supplement 23 · standardAP
2000-05-16Labeling · Supplement 22 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 21 · priorityAP
1995-03-23Manufacturing (CMC) · Supplement 18 · priorityAP
1986-08-11Labeling · Supplement 13AP
1985-12-04Labeling · Supplement 12AP
1982-09-30Manufacturing (CMC) · Supplement 7 · priorityAP
1981-12-09Labeling · Supplement 4AP
1981-11-04Labeling · Supplement 6AP
1980-09-29Manufacturing (CMC) · Supplement 3 · priorityAP
1979-12-20Manufacturing (CMC) · Supplement 2 · priorityAP
1979-05-03Labeling · Supplement 1AP
1978-02-28Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · priority — Other Important Information from FDA ↗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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