APPLICATION
ANDA090939
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-11
LATEST ACTION
2024-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 10MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 20MG BASE · TABLET · ORAL
Approval history
2024-10-25Labeling · Supplement 30 · standardAP
2024-10-25Labeling · Supplement 29 · standardAP
2024-10-25Labeling · Supplement 25 · standardAP
2024-10-25Labeling · Supplement 31 · standardAP
2024-10-25Labeling · Supplement 28 · standardAP
2023-04-06Labeling · Supplement 24 · standardAP
2023-04-06Labeling · Supplement 20 · standardAP
2023-04-06Labeling · Supplement 17 · standardAP
2023-04-06Labeling · Supplement 15 · standardAP
2016-03-23Manufacturing (CMC) · Supplement 13 · unknownAP
2015-08-31Labeling · Supplement 10 · standardAP
2015-08-31Manufacturing (CMC) · Supplement 9 · unknownAP
2014-12-04Labeling · Supplement 7 · standardAP
2014-12-04Labeling · Supplement 6 · standardAP
2013-07-31Labeling · Supplement 2 · standardAP
2013-06-10Labeling · Supplement 1 · standardAP
2012-09-11OriginalAP
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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