Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Pfizer Inc
113480771
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BRAFTOVI
Product Details
NDC Product Code
70255-025Application Number
NDA210496Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 28, 2023EncorafenibActive
Code: 8L7891MRB6Class: ACTIBQuantity: 75 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6LClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT