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FDA ANDA · ANDA090432
ESCITALOPRAM
escitalopram oxalate
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA090432
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-11
LATEST ACTION
2024-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 10MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 20MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE · TABLET · ORAL
Approval history
2024-10-07Labeling · Supplement 12 · standardAP
2024-10-07Labeling · Supplement 27 · standardAP
2024-10-07Labeling · Supplement 15 · standardAP
2024-10-07Labeling · Supplement 21 · standardAP
2024-10-07Labeling · Supplement 18 · standardAP
2024-10-07Labeling · Supplement 24 · standardAP
2015-11-12Labeling · Supplement 9 · standardAP
2014-09-15Labeling · Supplement 8 · standardAP
2014-05-20Manufacturing (CMC) · Supplement 6 · unknownAP
2013-05-31Labeling · Supplement 2 · 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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