ents
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERRIC OXIDE YELLOW
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color YELLOW Score no score
Shape FREEFORM (oblong) Size 14mm
Flavor Imprint Code RTG;200
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0173-0812-59 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022345 04/19/2012
POTIGA
ezogabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0813
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZOGABINE (EZOGABINE) EZOGABINE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
FERRIC OXIDE YELLOW
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color GREEN Score no score
Shape FREEFORM (oblong) Size 16mm
Flavor Imprint Code RTG;300
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0173-0813-59 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022345 04/19/2012
POTIGA
ezogabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0814
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZOGABINE (EZOGABINE) EZOGABINE 400 mg
Inactive Ingredients
Ingredient Name Strength
COCHINEAL
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color PURPLE Score no score
Shape FREEFORM (oblong) Size 18mm
Flavor Imprint Code RTG;400
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0173-0814-59 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022345 04/19/2012 |
