APPLICATION
ANDA090374
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-17
LATEST ACTION
2019-10-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZALEPLONPrescription
ZALEPLON 10MG · CAPSULE · ORAL
ZALEPLONPrescription
ZALEPLON 5MG · CAPSULE · ORAL
Approval history
2019-10-21Labeling · Supplement 2 · standardAP
2019-10-21Labeling · Supplement 3 · standardAP
2014-03-11Labeling · Supplement 1 · standardAP
2009-09-17OriginalAP
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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