APPLICATION
ANDA077238
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-06
LATEST ACTION
2024-06-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ZALEPLONDiscontinued
ZALEPLON 10MG · CAPSULE · ORAL
ZALEPLONDiscontinued
ZALEPLON 5MG · CAPSULE · ORAL
Approval history
2024-06-13Labeling · Supplement 8 · standardAP
2015-07-06Labeling · Supplement 5 · 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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