APPLICATION
ANDA078147
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-25
LATEST ACTION
2019-12-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ZALEPLONDiscontinued
ZALEPLON 10MG · CAPSULE · ORAL
ZALEPLONDiscontinued
ZALEPLON 5MG · CAPSULE · ORAL
Approval history
2019-12-06Labeling · Supplement 2 · 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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