ACTIVE SUBSTANCE / INN

MYCOPHENOLATE MOFETIL

Brand name(s): Myfenax, Myclausen, CELLCEPT, Mycophenolate mofetil Teva, CellCept, MYCOPHENOLATE MOFETIL, MYHIBBIN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Graft Rejection
NDA216482
ACTIVE SUBSTANCE
Mycophenolate Mofetil
REGULATORS
FDA · EMA
SPONSORS / MAH
AZURITY, ROCHE PALO, ALKEM LABS LTD
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MYCOPHENOLATE MOFETILANDA090419APOTEX CORPDiscontinued
MYCOPHENOLATE MOFETILANDA200197ALKEM LABS LTDPrescription
CELLCEPTNDA050722ROCHE PALOPrescription
MYHIBBINNDA216482AZURITYPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
CellCeptRoche Registration GmbHAuthorised14/02/1996Graft Rejection
Mycophenolate mofetil TevaTeva Pharma B.V.Authorised21/02/2008Graft Rejection
MyfenaxTeva B.V.Authorised21/02/2008Graft Rejection
MyclausenPassauer Pharma GmbHAuthorised07/10/2010Graft Rejection

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