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FDA NDA · NDA021365

LEXAPRO

Sponsor: ABBVIE

APPLICATION
NDA021365
TYPE
NDA
ORIGINAL APPROVAL
2002-11-27
LATEST ACTION
2024-04-19
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LEXAPRO · ReferenceDiscontinued
ESCITALOPRAM OXALATE EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2024-04-19Labeling · Supplement 41 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 40 · standard — Label ↗AP
2023-05-12Efficacy · Supplement 39 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 38 · 901 required — Letter ↗AP
2020-08-28Labeling · Supplement 37 · standard — Letter ↗AP
2019-01-11Labeling · Supplement 36 · standard — Label ↗AP
2017-01-04Labeling · Supplement 35 · 901 required — Label ↗AP
2014-10-31Labeling · Supplement 32 · standard — Letter ↗AP
2014-07-08Labeling · Supplement 33 · 901 required — Letter ↗AP
2012-12-03Labeling · Supplement 30 · standard — Letter ↗AP
2011-05-12Labeling · Supplement 24 · standard — Letter ↗AP
2011-03-11Labeling · Supplement 25 · unknown — Letter ↗AP
2009-03-19Efficacy · Supplement 21 · unknown — Letter ↗AP
2009-03-19Efficacy · Supplement 22 · unknown — Letter ↗AP
2009-01-30Labeling · Supplement 23 · standard — Label ↗AP
2008-10-11Labeling · Supplement 19 · standard — Letter ↗AP
2008-09-18Labeling · Supplement 18 · standard — Letter ↗AP
2007-08-02Labeling · Supplement 16 · standardAP
2005-02-18Labeling · Supplement 12 · standard — Letter ↗AP
2005-01-11Labeling · Supplement 7 · standard — Letter ↗AP
2004-05-20Labeling · Supplement 8 · standard — Letter ↗AP
2004-04-08Supplement · Supplement 5 · standardAP
2003-12-18Efficacy · Supplement 1 · standard — Letter ↗AP
2003-12-18Efficacy · Supplement 4 · standard — Letter ↗AP
2002-11-27Type 3 - New Dosage Form · Original · standard — Review ↗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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