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FDA NDA · NDA021323

LEXAPRO

escitalopram

Sponsor: ABBVIE

APPLICATION
NDA021323
TYPE
NDA
ORIGINAL APPROVAL
2002-08-14
LATEST ACTION
2024-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEXAPRO · ReferencePrescription
ESCITALOPRAM OXALATE EQ 20MG BASE · TABLET · ORAL
LEXAPRO · ReferencePrescription
ESCITALOPRAM OXALATE EQ 5MG BASE · TABLET · ORAL
LEXAPRO · ReferencePrescription
ESCITALOPRAM OXALATE EQ 10MG BASE · TABLET · ORAL

Approval history

2024-04-19Labeling · Supplement 58 · standardLetterAP
2023-08-18Labeling · Supplement 57 · standardLabelAP
2023-05-12Efficacy · Supplement 55 · standardLetterAP
2021-09-20Labeling · Supplement 53 · 901 requiredLetterAP
2020-08-28Labeling · Supplement 52 · standardLetterAP
2019-01-11Labeling · Supplement 51 · standardLabelAP
2017-01-04Labeling · Supplement 47 · 901 requiredLabelAP
2016-01-28Manufacturing (CMC) · Supplement 46 · standardAP
2014-10-31Labeling · Supplement 44 · standardLabelAP
2014-07-08Labeling · Supplement 45 · 901 requiredLetterAP
2013-05-29Manufacturing (CMC) · Supplement 43 · standardAP
2013-03-07Manufacturing (CMC) · Supplement 39 · standardAP
2012-12-03Labeling · Supplement 40 · standardLabelAP
2011-05-12Labeling · Supplement 33 · standardLetterAP
2011-03-11Labeling · Supplement 35 · unknownLabelAP
2009-03-19Efficacy · Supplement 30 · unknownReviewAP
2009-03-19Efficacy · Supplement 31 · unknownLetterAP
2009-01-30Labeling · Supplement 32 · standardLabelAP
2008-10-11Labeling · Supplement 29 · standardLetterAP
2008-09-18Labeling · Supplement 28 · standardLetterAP
2007-08-02Labeling · Supplement 25 · standardLabelAP
2005-02-18Labeling · Supplement 20 · standardLetterAP
2005-01-11Labeling · Supplement 14 · standardLetterAP
2004-05-20Labeling · Supplement 15 · standardLetterAP
2004-04-08Supplement · Supplement 10 · standardAP
2003-12-18Efficacy · Supplement 3 · standardLabelAP
2003-12-18Efficacy · Supplement 7 · standardLabelAP
2002-12-13Manufacturing (CMC) · Supplement 2 · standardAP
2002-08-29Efficacy · Supplement 1 · standardReviewAP
2002-08-14Type 3 - New Dosage Form · Original · standardReviewAP
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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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