← FDA DRUG APPROVALS

FDA NDA · NDA021431

CAMPRAL

Sponsor: FOREST LABS

APPLICATION
NDA021431
TYPE
NDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2015-08-10
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

CAMPRAL · ReferenceDiscontinued
ACAMPROSATE CALCIUM 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL

Approval history

2015-08-10Manufacturing (CMC) · Supplement 17 · priorityAP
2013-09-20Manufacturing (CMC) · Supplement 16 · priorityAP
2012-01-30Labeling · Supplement 15 · unknown — Label ↗AP
2010-12-13Labeling · Supplement 13 · unknown — Label ↗AP
2004-07-29Type 1 - New Molecular Entity · Original · priority — Review ↗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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