APPLICATION
ANDA077031
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-28
LATEST ACTION
2024-07-29
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
2024-07-29Labeling · Supplement 44 · standardAP
2023-10-30Labeling · Supplement 43 · standardAP
2022-08-31Labeling · Supplement 38 · standardAP
2022-08-31Labeling · Supplement 37 · standardAP
2022-08-31Labeling · Supplement 33 · standardAP
2022-08-31Labeling · Supplement 31 · standardAP
2014-09-26Labeling · Supplement 30 · standardAP
2014-09-26Labeling · Supplement 29 · standardAP
2013-04-30Labeling · Supplement 23 · standardAP
2012-04-25Labeling · Supplement 18AP
2012-04-25Labeling · Supplement 21 · standardAP
2009-03-06Labeling · Supplement 14AP
2009-01-14Labeling · Supplement 11AP
2008-07-02Labeling · Supplement 10AP
2007-10-25Labeling · Supplement 8AP
2007-10-25Labeling · Supplement 9AP
2007-06-28Labeling · Supplement 6AP
2007-04-09Labeling · Supplement 4AP
2006-04-07Labeling · Supplement 2AP
2006-02-06Labeling · 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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