APPLICATION
ANDA077042
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-05
LATEST ACTION
2024-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CITALOPRAM HYDROBROMIDEPrescription
CITALOPRAM HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEPrescription
CITALOPRAM HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEPrescription
CITALOPRAM HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2024-09-19Labeling · Supplement 38 · standardAP
2024-09-19Labeling · Supplement 43 · standardAP
2022-09-16Labeling · Supplement 33 · standardAP
2022-09-16Labeling · Supplement 25 · standardAP
2022-09-16Labeling · Supplement 28 · standardAP
2022-09-16Labeling · Supplement 34 · standardAP
2015-12-01Labeling · Supplement 24 · standardAP
2013-04-30Labeling · Supplement 18 · standardAP
2013-04-30Labeling · Supplement 20 · standardAP
2012-04-25Labeling · Supplement 17AP
2009-09-28Labeling · Supplement 14AP
2008-07-07Labeling · Supplement 13AP
2007-11-01Labeling · Supplement 11AP
2007-11-01Labeling · Supplement 12AP
2007-06-27Labeling · Supplement 8AP
2005-08-16Labeling · Supplement 2AP
2005-04-29Labeling · Supplement 1AP
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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