APPLICATION
ANDA077629
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-14
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CITALOPRAM HYDROBROMIDEPrescription
CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-18Labeling · Supplement 18 · standardAP
2021-09-21Labeling · Supplement 16 · standardAP
2021-09-13Labeling · Supplement 14 · standardAP
2021-09-13Labeling · Supplement 15 · standardAP
2017-01-04Labeling · Supplement 13 · standardAP
2014-07-17Labeling · Supplement 11 · standardAP
2013-11-01Labeling · Supplement 7 · standardAP
2013-11-01Labeling · Supplement 8 · standardAP
2012-05-21Labeling · Supplement 5AP
2009-03-11Labeling · Supplement 4AP
2008-07-02Labeling · Supplement 3AP
2007-07-12Labeling · Supplement 1AP
2007-07-02Labeling · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.