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ACTIVE SUBSTANCE / INN

FENTANYL

Brand name(s): Effentora, FENTANYL-87, FENTANYL-75, Ionsys, FENTANYL-100, FENTANYL-50, FENTANYL-62, FENTANYL-12, PecFent, FENTANYL, FENTANYL-25, FENTANYL-37, Instanyl
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
Pain;Cancer
ANDA077154
ACTIVE SUBSTANCE
Fentanyl
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International NV, Phoenix Labs Unlimited Company, NOVEN
TOTAL APPLICATIONS
15
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FENTANYL-50ANDA077775NOVENDiscontinued
FENTANYL-75ANDA077775NOVENDiscontinued
FENTANYL-25ANDA077775NOVENDiscontinued
FENTANYL-100ANDA077775NOVENDiscontinued
FENTANYLANDA202577MYLAN PHARMS INCNone (Tentative Approval)
FENTANYL-87ANDA209655ZYDUS PHARMSDiscontinued
FENTANYL-62ANDA209655ZYDUS PHARMSDiscontinued
FENTANYL-37ANDA209655ZYDUS PHARMSDiscontinued
FENTANYL-12ANDA209655ZYDUS PHARMSDiscontinued
FENTANYL-75ANDA077154SPECGX LLCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
EffentoraPhoenix Labs Unlimited CompanyAuthorised04/04/2008Pain;Cancer
InstanylIstituto Gentili S.r.l.Authorised20/07/2009Pain;Cancer
PecFentGruenenthal GmbHAuthorised31/08/2010Pain;Cancer
IonsysIncline Therapeutics Europe LtdWithdrawn18/11/2015Pain, Postoperative
IonsysJanssen-Cilag International NVWithdrawn24/01/2006Pain, Postoperative

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