APPLICATION
ANDA202227
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-14
LATEST ACTION
2024-04-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE/5ML · SOLUTION · ORAL
Approval history
2024-04-15Labeling · Supplement 19 · standardAP
2021-12-10Labeling · Supplement 14 · standardAP
2021-09-20Labeling · Supplement 12 · standardAP
2021-09-03Labeling · Supplement 5 · standardAP
2021-09-03Labeling · Supplement 10 · standardAP
2021-09-03Labeling · Supplement 6 · standardAP
2015-05-14Labeling · Supplement 3 · standardAP
2014-12-10Labeling · Supplement 2 · standardAP
2013-12-19Labeling · Supplement 1 · standardAP
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.