H.P. ACTHAR(repository corticotropin)injection(十六)
tration INTRAMUSCULAR,SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Corticotropin (Corticotropin) Corticotropin 80[USP'U] in1mL
Inactive Ingredients
Ingredient Name Strength
Gelatin
Phenol
Cysteine
Sodium Hydroxide
Acetic acid
Water
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63004-7731-1 1 VIAL, MULTI-DOSE ( VIAL) in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON(63004-7731-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022432 10/15/2010
Labeler -Questcor Pharmaceuticals, Inc. (625130828)
Establishment
Name Address ID/FEI Operations
Cangene bioPharma 050783398 manufacture
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