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ACTIVE SUBSTANCE / INN

ZALEPLON

Brand name(s): SONATA, ZALEPLON, Sonata, Zerene
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
ANDA090374
ANDA078147
ACTIVE SUBSTANCE
Zaleplon
REGULATORS
FDA · EMA
SPONSORS / MAH
PFIZER, HIKMA PHARMS, ORBION PHARMS
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ZALEPLONANDA078147HIKMA PHARMSDiscontinued
ZALEPLONANDA090374ORBION PHARMSPrescription
SONATANDA020859PFIZERDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SonataMeda ABWithdrawn12/03/1999Sleep Initiation and Maintenance Disorders
ZereneMeda ABWithdrawn12/03/1999Sleep Initiation and Maintenance Disorders

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