APPLICATION
ANDA077032
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-12
LATEST ACTION
2024-11-26
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
2024-11-26Labeling · Supplement 25 · standardAP
2024-11-26Labeling · Supplement 28 · standardAP
2024-11-26Labeling · Supplement 26 · standardAP
2012-12-27Labeling · Supplement 17AP
2012-12-27Labeling · Supplement 21 · standardAP
2010-08-04Manufacturing (CMC) · Supplement 15AP
2009-03-06Labeling · Supplement 14AP
2009-02-19Labeling · Supplement 13AP
2007-10-25Labeling · Supplement 11AP
2007-06-28Labeling · Supplement 10AP
2006-09-13Labeling · Supplement 7AP
2006-02-14Labeling · Supplement 6AP
2005-05-27Labeling · Supplement 3AP
2005-05-11Labeling · Supplement 2AP
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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