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ACTIVE SUBSTANCE / INN

POSACONAZOLE

Brand name(s): NOXAFIL, Posaconazole AHCL, Noxafil, Posaconazole Accord, NOXAFIL POWDERMIX KIT, Posaconazole SP, POSACONAZOLE
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
AUTHORISED
ANDA217709
NDA214770
ACTIVE SUBSTANCE
Posaconazole
REGULATORS
FDA · EMA
SPONSORS / MAH
Schering-Plough Europe, Merck Sharp and Dohme B.V, Accord Healthcare S.L.U.
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
POSACONAZOLEANDA207355ACTAVIS LABS FL INCDiscontinued
POSACONAZOLEANDA212226SPECGX LLCPrescription
NOXAFILNDA022027SCHERINGPrescription
NOXAFILNDA205053MERCK SHARP DOHMEDiscontinued
NOXAFIL POWDERMIX KITNDA214770MSD MERCK COPrescription
POSACONAZOLEANDA217709HAINAN POLY PHARMNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
NoxafilMerck Sharp and Dohme B.VAuthorised25/10/2005Candidiasis;Mycoses;Coccidioidomycosis;Aspergillosis
Posaconazole AccordAccord Healthcare S.L.U.Authorised25/07/2019Mycoses
Posaconazole AHCLAccord Healthcare S.L.U.Authorised25/07/2019Mycoses
Posaconazole SPSchering-Plough EuropeLapsed25/10/2005Candidiasis;Mycoses;Coccidioidomycosis;Aspergillosis

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