5
Part 3 5
Part 4 30
Part 1 of 4
STRATTERA
atomoxetine hydrochloride capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8) Atomoxetine 25 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
STARCH, Corn (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
Gelatin (UNII: 2G86QN327L)
sodium lauryl sulfate (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
Color WHITE (opaque white) , BLUE (opaque blue) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code LILLY;3228;25;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411
Part 2 of 4
STRATTERA
atomoxetine hydrochloride capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8) Atomoxetine 40 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
STARCH, Corn (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
Gelatin (UNII: 2G86QN327L)
sodium lauryl sulfate (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
Color BLUE (opaque blue) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code LILLY;3229;40;mg
Contains
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021411
Part 3 of 4
STRATTERA
atomoxetine hydrochloride capsule
PRODUCT INFORMATION
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Atomoxetine hydrochloride (UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8) Atomoxetine 60 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
STARCH, Corn (UNII: O8232NY3SJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
Gelatin (UNII: 2G86QN327L)
sodium lauryl sulfate (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
Color BLUE (opaque blue) , yellow (gold) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code LILLY;3239;60;mg
Contains
MARKET |
