APPLICATION
ANDA091103
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-03
LATEST ACTION
2015-01-30
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
2015-01-30Labeling · Supplement 1 · standardAP
2013-04-03OriginalAP
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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