NDA NDA203441 12/21/2012
Part 2 of 2
WATER
sterile water solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
water (water) water 0.5 mg
Packaging
# Item Code Package Description
1 1 SOLUTION in 1 SYRINGE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
GATTEX
teduglutide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68875-0102
Packaging
# Item Code Package Description
1 NDC:68875-0102-1 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 30
Part 2 1 SYRINGE, PLASTIC 3
Part 1 of 2
GATTEX
teduglutide injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teduglutide (teduglutide) teduglutide 5 mg
Inactive Ingredients
Ingredient Name Strength
histidine 3.88 mg
mannitol 15 mg
sodium phosphate, monobasic, monohydrate 0.644 mg
sodium phosphate, dibasic, heptahydrate 3.434 mg
Packaging
# Item Code Package Description
1 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
Part 2 of 2
WATER
sterile water so
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
water (water) water 0.5 mg
Packaging
# Item Code Package Description
1 30 SOLUTION in 1 SYRINGE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
Labeler - NPS Pharmaceuticals (181871427)
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