APPLICATION
ANDA078216
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-27
LATEST ACTION
2024-09-18
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
2024-09-18Labeling · Supplement 40 · standardAP
2024-09-18Labeling · Supplement 39 · standardAP
2024-03-28Labeling · Supplement 37 · standardAP
2022-10-05Labeling · Supplement 34 · standardAP
2022-10-05Labeling · Supplement 32 · standardAP
2022-10-05Labeling · Supplement 29 · standardAP
2022-10-05Labeling · Supplement 33 · standardAP
2014-12-10Labeling · Supplement 22 · standardAP
2013-03-28Labeling · Supplement 20 · standardAP
2012-06-26Labeling · Supplement 18 · standardAP
2012-06-26Labeling · Supplement 16AP
2011-01-20Labeling · Supplement 9AP
2009-06-22Labeling · Supplement 10AP
2009-01-23Labeling · Supplement 7AP
2008-08-13Labeling · Supplement 3AP
2007-10-25Labeling · 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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