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ACTIVE SUBSTANCE / INN

DARUNAVIR

Brand name(s): DARUNAVIR, Darunavir Krka, Darunavir Krka d.d., SYMTUZA, Prezista, PREZISTA, Darunavir Viatris (previously Darunavir Mylan)
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
EXPIRED
ANDA216168
NDA202895
ACTIVE SUBSTANCE
Darunavir
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International NV, JANSSEN PRODS, CIPLA LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DARUNAVIRANDA207189CIPLA LTDNone (Tentative Approval)
DARUNAVIRANDA216168ANNORA PHARMAPrescription
SYMTUZANDA210455JANSSEN PRODSPrescription
PREZISTANDA202895JANSSEN PRODSPrescription
PREZISTANDA021976JANSSEN PRODSDiscontinued
DARUNAVIRANDA202118TEVA PHARMS USADiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Darunavir Viatris (previously Darunavir Mylan)Viatris LimitedAuthorised03/01/2017HIV Infections
Darunavir KrkaKRKA, d.d., Novo mestoAuthorised26/01/2018HIV Infections
PrezistaJanssen-Cilag International NVAuthorised11/02/2007HIV Infections
Darunavir Krka d.d.KRKA, d.d., Novo mestoExpired18/01/2018HIV Infections

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