ription
1 NDC:0173-0858-13 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204114 06/17/2013
Mekinist
trametinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0848
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMETINIB DIMETHYL SULFOXIDE (TRAMETINIB) TRAMETINIB 2 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code GS;HMJ
Contains
Packaging
Item Code Package Description
1 NDC:0173-0848-13 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204114 06/17/2013
Labeler - GlaxoSmithKline LLC (167380711)
Revised: 05/2013
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