APPLICATION
ANDA202929
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-30
LATEST ACTION
2023-06-07
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
2023-06-07Labeling · Supplement 26 · standardAP
2023-05-02Labeling · Supplement 27 · standardAP
2019-12-03Labeling · Supplement 8 · standardAP
2019-12-03Labeling · Supplement 13 · standardAP
2019-12-03Labeling · Supplement 9 · standardAP
2015-01-30UNKNOWN · OriginalAP
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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