bsp; 1 mL In 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103132 09/11/2009
Part 2 of 2
STERILE WATER
water injection, solution
Product Information
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
Water
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 1 mL In 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103132 09/11/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103132 09/11/2009
INTRON A
interferon alfa-2b injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1168
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Interferon alfa-2b (Interferon alfa-2b) Interferon alfa-2b 11.6 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride 7.5 mg in 1 mL
sodium phosphate, dibasic 1.8 mg in 1 mL
sodium phosphate, monobasic 1.3 mg in 1 mL
edetate disodium 0.1 mg in 1 mL
polysorbate 80 0.1 mg in 1 mL
metacresol 1.5 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1168-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE
1 3.8 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0085-1168-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103132 09/11/2009
INTRON A
interferon alfa-2b injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1133
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR, INTRALESIONAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Interferon alfa-2b (Interferon alfa-2b) Interferon alfa-2b 19.2 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride 7.5 mg in 1 mL
sodium phosphate, dibasic 1.8 mg in