MedPath
FDA Approval

ZELBORAF

November 27, 2023

HUMAN PRESCRIPTION DRUG LABEL

Vemurafenib(240 mg in 1 1)

Manufacturing Establishments (1)

F. Hoffmann-La Roche AG

Genentech, Inc.

482242971

Products (1)

ZELBORAF

50242-090

NDA202429

NDA (C73594)

ORAL

November 27, 2023

Code: 207SMY3FQTClass: ACTIBQuantity: 240 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)Inactive
Code: 24P2YXD2PWClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
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