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ACTIVE SUBSTANCE / INN

ROFLUMILAST

Brand name(s): ZORYVE, Daliresp, Libertek, DALIRESP, Daxas, ROFLUMILAST
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
NDA022522
ANDA208213
ACTIVE SUBSTANCE
Roflumilast
REGULATORS
FDA · EMA
SPONSORS / MAH
AstraZeneca AB, PHARMOBEDIENT, ASTRAZENECA
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ROFLUMILASTANDA208213HETERO LABS LTD IIIPrescription
ZORYVENDA217242ARCUTISPrescription
ROFLUMILASTANDA208257PHARMOBEDIENTDiscontinued
DALIRESPNDA022522ASTRAZENECAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
DaxasAstraZeneca ABAuthorised05/07/2010Pulmonary Disease, Chronic Obstructive
LibertekAstraZeneca ABWithdrawn28/02/2011Pulmonary Disease, Chronic Obstructive
DalirespAstraZeneca ABWithdrawn28/02/2011Pulmonary Disease, Chronic Obstructive

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