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FDA ANDA · ANDA077237

ZALEPLON

Sponsor: HIKMA

APPLICATION
ANDA077237
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-06
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 4 · standardAP
2019-10-21Labeling · Supplement 3 · standardAP
2014-03-11Labeling · Supplement 1 · standardAP
2008-06-06Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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