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FDA ANDA · ANDA078989

ZALEPLON

Sponsor: UNICHEM

APPLICATION
ANDA078989
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-06
LATEST ACTION
2019-10-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZALEPLONPrescription
ZALEPLON 5MG · CAPSULE · ORAL
ZALEPLONPrescription
ZALEPLON 10MG · CAPSULE · ORAL

Approval history

2019-10-03Labeling · Supplement 10 · standardAP
2019-10-03Labeling · Supplement 9 · standardAP
2014-03-12Labeling · Supplement 3 · standardAP
2008-06-06Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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