BRAFTOVI- encorafenib capsule 
Array BioPharma Inc.

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BRAFTOVI® 50 mg

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack

EXP
Lot

BRAFTOVI® 50 mg

capsules
encorafenib

Pierre Fabre Médicament

XXXXX

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

BRAFTOVI® 50 mg

hard capsules

encorafenib

Oral use

28 | hard capsules

Pierre Fabre
Médicament

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
BRAFTOVI 
encorafenib capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70255-050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENCORAFENIB (UNII: 8L7891MRB6) (ENCORAFENIB - UNII:8L7891MRB6) ENCORAFENIB50 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCCINIC ACID (UNII: AB6MNQ6J6L)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorORANGE (Swedish) , PINK (Biege) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint Code A;LGX;50mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70255-050-287 in 1 CARTON03/01/2022
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/01/2022
Labeler - Array BioPharma Inc. (004047838)
Establishment
NameAddressID/FEIBusiness Operations
Finorga640422218API MANUFACTURE(70255-050)

Revised: 7/2023
Document Id: efa87228-e879-4356-98fe-8dec8f1cfc1f
Set id: 40e2f621-90c3-4f06-9757-683f9a6b639e
Version: 2
Effective Time: 20230728
 
Array BioPharma Inc.