COTELLIC- cobimetinib fumarate tablet, film coated 
Delpharm Milano Srl

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Cotellic label 1Cotellic label 2

COTELLIC 
cobimetinib fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71973-717
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COBIMETINIB FUMARATE (UNII: 6EXI96H8SV) (COBIMETINIB - UNII:ER29L26N1X) COBIMETINIB20 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code COB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71973-717-0163 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2015
2NDC:71973-717-8663 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20619211/10/2015
Labeler - Delpharm Milano Srl (438660140)
Establishment
NameAddressID/FEIBusiness Operations
Delpharm Milano Srl438660140pack(71973-717)

Revised: 2/2018
Document Id: 63658132-197c-b857-e053-2a91aa0ad6c7
Set id: 63658132-197b-b857-e053-2a91aa0ad6c7
Version: 1
Effective Time: 20180207
 
Delpharm Milano Srl