APPLICATION
ANDA077289
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-30
LATEST ACTION
2024-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2024-09-19Labeling · Supplement 34 · standardAP
2024-01-08Labeling · Supplement 32 · standardAP
2024-01-08Labeling · Supplement 24 · standardAP
2024-01-08Labeling · Supplement 20 · standardAP
2024-01-08Labeling · Supplement 29 · standardAP
2024-01-08Labeling · Supplement 33 · standardAP
2024-01-08Labeling · Supplement 31 · standardAP
2014-11-03Labeling · Supplement 18 · standardAP
2014-11-03Labeling · Supplement 19 · standardAP
2014-11-03Labeling · Supplement 15 · standardAP
2012-04-25Labeling · Supplement 8AP
2011-01-13Manufacturing (CMC) · Supplement 5AP
2008-04-03Labeling · Supplement 3AP
2008-03-20Manufacturing (CMC) · Supplement 1AP
2006-11-30OriginalAP
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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