0085-1235-01)
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) 0085-1254
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Interferon alfa-2b (Interferon alfa-2b) Interferon alfa-2b 38.4 ug in 0.2 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 0085-1254-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE
1 1.5 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0085-1254-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103132 09/11/2009
Labeler - Schering Corporation (001317601)
Establishment
Name Address ID/FEI Operations
SCHERING PLOUGH BRINNY CO 986467223 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Hollister-Stier Laboratories LLC 069263643 MANUFACTURE
Revised: 08/2009Schering Corporatio