APPLICATION
ANDA079062
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-02
LATEST ACTION
2025-01-14
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-01-14Labeling · Supplement 27 · standardAP
2025-01-14Labeling · Supplement 25 · standardAP
2023-08-18Labeling · Supplement 22 · standardAP
2022-11-23Labeling · Supplement 19 · standardAP
2021-09-20Labeling · Supplement 16 · standardAP
2021-09-07Labeling · Supplement 14 · standardAP
2021-09-07Labeling · Supplement 15 · standardAP
2021-09-07Labeling · Supplement 11 · standardAP
2021-09-07Labeling · Supplement 9 · standardAP
2016-01-05Labeling · Supplement 5 · standardAP
2014-09-15Labeling · Supplement 3 · standardAP
2013-05-31Labeling · Supplement 1 · standardAP
2012-04-02OriginalAP
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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