← FDA DRUG APPROVALS

FDA NDA · NDA020822

CELEXA

citalopram

Sponsor: ABBVIE

APPLICATION
NDA020822
TYPE
NDA
ORIGINAL APPROVAL
1998-07-17
LATEST ACTION
2024-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

CELEXA · ReferencePrescription
CITALOPRAM HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL
CELEXA · ReferencePrescription
CITALOPRAM HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL
CELEXADiscontinued
CITALOPRAM HYDROBROMIDE EQ 60MG BASE · TABLET · ORAL
CELEXA · ReferencePrescription
CITALOPRAM HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2024-04-19Labeling · Supplement 55 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 54 · standard — Label ↗AP
2022-02-04Labeling · Supplement 41 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 52 · 901 required — Letter ↗AP
2019-01-11Labeling · Supplement 51 · standard — Label ↗AP
2017-01-04Labeling · Supplement 47 · 901 required — Label ↗AP
2014-07-08Labeling · Supplement 46 · 901 required — Label ↗AP
2014-04-16Labeling · Supplement 45 · standard — Letter ↗AP
2013-06-17Manufacturing (CMC) · Supplement 44 · standardAP
2012-12-03Labeling · Supplement 43 · standard — Label ↗AP
2012-03-27Labeling · Supplement 42 · standard — Review ↗AP
2011-08-12Labeling · Supplement 38 · standard — Review ↗AP
2011-08-12Labeling · Supplement 40 · unknown — Review ↗AP
2009-01-30Labeling · Supplement 37 · standard — Label ↗AP
2008-09-18Labeling · Supplement 35 · standard — Label ↗AP
2007-08-02Labeling · Supplement 34 · standard — Label ↗AP
2005-02-18Labeling · Supplement 29 · standard — Label ↗AP
2004-05-20Labeling · Supplement 27 · standard — Letter ↗AP
2004-04-08Labeling · Supplement 23 · standard — Letter ↗AP
2002-11-19Labeling · Supplement 19 · standard — Review ↗AP
2002-05-30Manufacturing (CMC) · Supplement 15 · standardAP
2001-07-10Manufacturing (CMC) · Supplement 14 · standardAP
2001-06-27Labeling · Supplement 11 · standardAP
2001-05-17Manufacturing (CMC) · Supplement 13 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 12 · standardAP
2000-07-13Manufacturing (CMC) · Supplement 7 · standardAP
2000-06-27Manufacturing (CMC) · Supplement 10 · standardAP
2000-04-27Manufacturing (CMC) · Supplement 8 · standardAP
1999-12-07Manufacturing (CMC) · Supplement 5 · standardAP
1999-12-07Manufacturing (CMC) · Supplement 6 · standardAP
1999-10-21Manufacturing (CMC) · Supplement 3 · standardAP
1999-10-19Manufacturing (CMC) · Supplement 1 · standardAP
1999-08-13Manufacturing (CMC) · Supplement 2 · standardAP
1998-07-17Type 1 - New Molecular Entity · Original · standard — Letter ↗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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