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FDA ANDA · ANDA078766

ESCITALOPRAM OXALATE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA078766
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-11
LATEST ACTION
2015-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESCITALOPRAM OXALATEDiscontinued
ESCITALOPRAM OXALATE EQ 10MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEDiscontinued
ESCITALOPRAM OXALATE EQ 20MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEDiscontinued
ESCITALOPRAM OXALATE EQ 5MG BASE · TABLET · ORAL

Approval history

2015-09-03Labeling · Supplement 3 · standardAP
2015-09-03Labeling · Supplement 4 · standardAP
2012-11-21Labeling · 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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