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FDA NDA · NDA019794

DEPAKOTE CP

Sponsor: ABBOTT

APPLICATION
NDA019794
TYPE
NDA
ORIGINAL APPROVAL
1990-07-11
LATEST ACTION
1996-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DEPAKOTE CPDiscontinued
DIVALPROEX SODIUM EQ 500MG BASE · TABLET, DELAYED RELEASE · ORAL
DEPAKOTE CPDiscontinued
DIVALPROEX SODIUM EQ 250MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

1996-12-02Manufacturing (CMC) · Supplement 2 · standardAP
1995-03-23Manufacturing (CMC) · Supplement 1 · standardAP
1990-07-11Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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