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ACTIVE SUBSTANCE / INN

IVACAFTOR

Brand name(s): SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED), IVACAFTOR, Kalydeco, KALYDECO, ORKAMBI
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
NDA217660
NDA207925
ACTIVE SUBSTANCE
Ivacaftor
REGULATORS
FDA · EMA
SPONSORS / MAH
Vertex Pharmaceuticals (Ireland) Limited, LUPIN LTD, VERTEX PHARMS INC
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ORKAMBINDA206038VERTEX PHARMS INCPrescription
SYMDEKO (COPACKAGED)NDA210491VERTEX PHARMS INCPrescription
IVACAFTORANDA216074LUPIN LTDNone (Tentative Approval)
TRIKAFTA (COPACKAGED)NDA217660VERTEX PHARMS INCPrescription
KALYDECONDA207925VERTEX PHARMS INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KalydecoVertex Pharmaceuticals (Ireland) LimitedAuthorised23/07/2012Cystic Fibrosis

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