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ACTIVE SUBSTANCE / INN

ORLISTAT

Brand name(s): Xenical, ALLI, XENICAL, Alli (previously Orlistat GSK)
FDA LISTED
EMA LISTED
PRESCRIPTION
OVER-THE-COUNTER
AUTHORISED
NDA021887
NDA020766
ACTIVE SUBSTANCE
Orlistat
REGULATORS
FDA · EMA
SPONSORS / MAH
CHEPLAPHARM Arzneimittel GmbH, HALEON US HOLDINGS, CHEPLAPHARM
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
XENICALNDA020766CHEPLAPHARMPrescription
ALLINDA021887HALEON US HOLDINGSOver-the-counter
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Alli (previously Orlistat GSK)Haleon Ireland Dungarvan LimitedAuthorised22/07/2007Obesity
XenicalCHEPLAPHARM Arzneimittel GmbHAuthorised29/07/1998Obesity

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