APPLICATION
ANDA208451
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-15
LATEST ACTION
2019-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESZOPICLONEPrescription
ESZOPICLONE 3MG · TABLET · ORAL
ESZOPICLONEPrescription
ESZOPICLONE 1MG · TABLET · ORAL
ESZOPICLONEPrescription
ESZOPICLONE 2MG · TABLET · ORAL
Approval history
2019-11-04Labeling · Supplement 2 · standardAP
2019-11-04Labeling · Supplement 5 · standardAP
2019-11-04Labeling · Supplement 3 · standardAP
2016-09-15UNKNOWN · Original · standardAP
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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