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FDA ANDA · ANDA091113

ESZOPICLONE

Sponsor: ORBION PHARMS

APPLICATION
ANDA091113
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-10
LATEST ACTION
2020-04-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2020-04-27Labeling · Supplement 3 · standardAP
2020-04-27Labeling · Supplement 6 · standardAP
2020-04-27Labeling · Supplement 4 · standardAP
2014-06-10OriginalAP
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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