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FDA ANDA · ANDA077048

CITALOPRAM HYDROBROMIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA077048
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-16
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2024-12-16Labeling · Supplement 26 · standardAP
2024-12-16Labeling · Supplement 23 · standardAP
2013-04-23Labeling · Supplement 19 · standardAP
2012-12-19Labeling · Supplement 18 · standardAP
2012-04-26Labeling · Supplement 17AP
2009-04-02Labeling · Supplement 13AP
2009-04-02Labeling · Supplement 14AP
2009-01-06Labeling · Supplement 12AP
2008-04-03Labeling · Supplement 9AP
2007-07-02Labeling · Supplement 8AP
2005-12-14Labeling · Supplement 3AP
2005-06-09Labeling · Supplement 2AP
2004-11-16OriginalOther Important Information from FDAAP
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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