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FDA ANDA · ANDA078169

ESCITALOPRAM

escitslopram

Sponsor: CHARTWELL RX

APPLICATION
ANDA078169
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-11
LATEST ACTION
2026-03-27
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

2026-03-27Labeling · Supplement 20 · standardAP
2026-03-27Labeling · Supplement 23 · standardAP
2026-03-27Labeling · Supplement 21 · standardAP
2026-03-27Manufacturing (CMC) · Supplement 13 · unknownAP
2026-03-27Labeling · Supplement 11 · standardAP
2026-03-27Labeling · Supplement 7 · standardAP
2026-03-27Labeling · Supplement 18 · standardAP
2026-03-27Labeling · Supplement 16 · standardAP
2026-03-27Labeling · Supplement 22 · standardAP
2015-06-25Labeling · Supplement 5 · standardAP
2014-12-13Labeling · Supplement 4 · standardAP
2013-07-31Labeling · Supplement 2 · standardAP
2012-09-11OriginalAP
VIEW ON DRUGS@FDA ↗

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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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