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FDA ANDA · ANDA091153

ESZOPICLONE

Sponsor: HIKMA

APPLICATION
ANDA091153
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-15
LATEST ACTION
2019-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESZOPICLONEDiscontinued
ESZOPICLONE 3MG · TABLET · ORAL
ESZOPICLONEDiscontinued
ESZOPICLONE 1MG · TABLET · ORAL
ESZOPICLONEDiscontinued
ESZOPICLONE 2MG · TABLET · ORAL

Approval history

2019-12-11Labeling · Supplement 3 · standardAP
2019-12-11Labeling · Supplement 4 · standardAP
2019-12-11Labeling · Supplement 2 · standardAP
2015-01-30Labeling · Supplement 1 · standardAP
2014-04-15OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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