APPLICATION
ANDA202221
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-12
LATEST ACTION
2024-05-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE/5ML · SOLUTION · ORAL
Approval history
2024-05-30Labeling · Supplement 15 · standardAP
2024-05-30Labeling · Supplement 11 · standardAP
2024-05-30Labeling · Supplement 14 · standardAP
2024-05-30Labeling · Supplement 12 · standardAP
2024-05-30Labeling · Supplement 10 · standardAP
2022-11-29Labeling · Supplement 9 · standardAP
2021-09-21Labeling · Supplement 6 · standardAP
2021-08-03Manufacturing (CMC) · Supplement 5 · unknownAP
2021-08-03Labeling · Supplement 4 · standardAP
2021-08-03Labeling · Supplement 2 · standardAP
2016-02-02Labeling · Supplement 1 · standardAP
2012-06-12OriginalAP
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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