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ACTIVE SUBSTANCE / INN

PITOLISANT

Brand name(s): PITOLISANT, Wakix, Ozawade
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA218832
Sleep Apnea, Obstructive
ACTIVE SUBSTANCE
Pitolisant
REGULATORS
FDA · EMA
SPONSORS / MAH
Bioprojet Pharma, ANNORA PHARMA PRIVATE LIMITED
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PITOLISANTANDA218832ANNORA PHARMA PRIVATE LIMITEDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OzawadeBioprojet PharmaAuthorised01/09/2021Sleep Apnea, Obstructive
WakixBioprojet PharmaAuthorised31/03/2016Narcolepsy

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