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FDA NDA · NDA021046

CELEXA

Sponsor: FOREST LABS

APPLICATION
NDA021046
TYPE
NDA
ORIGINAL APPROVAL
1999-12-22
LATEST ACTION
2012-12-03
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CELEXA · ReferenceDiscontinued
CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2012-12-03Labeling · Supplement 20 · standard — Letter ↗AP
2012-03-27Labeling · Supplement 19 · standard — Review ↗AP
2011-08-12Labeling · Supplement 16 · standard — Label ↗AP
2011-08-12Labeling · Supplement 17 · unknown — Review ↗AP
2009-01-30Labeling · Supplement 15 · standard — Label ↗AP
2008-09-18Labeling · Supplement 14 · standard — Letter ↗AP
2007-08-02Labeling · Supplement 13 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 9 · standard — Letter ↗AP
2004-05-20Labeling · Supplement 7 · standard — Letter ↗AP
2004-04-08Labeling · Supplement 5 · standard — Letter ↗AP
2002-11-19Labeling · Supplement 3 · standard — Letter ↗AP
2000-12-01Manufacturing (CMC) · Supplement 1 · standardAP
1999-12-22Type 3 - New Dosage Form · Original · standard — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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