05/01/1986
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103960 05/01/1986
HUMATE-P
antihemophilic factor/von willebrand factor complex (human) kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63833-617
Packaging
# NDC Package Description Multilevel Packaging
1 63833-617-02 1KITIn1CARTON None
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1 1VIAL 15mL
Part2 1VIAL, SINGLE-DOSE 15mL
Part 1of2
HUMATE-P
antihemophilic factor/von willebrand factor complex (human) injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX(ANTIHEMOPHILIC FACTOR HUMANandVON WILLEBRAND FACTOR HUMAN) HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX 80[iU] in1mL
Inactive Ingredients
Ingredient Name Strength
Glycine 33mg in1mL
Sodium Citrate 9.3mg in1mL
Sodium Chloride 5.3mg in1mL
albumin (human) 16mg in1mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 15mLIn1VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103960 05/01/1986
Part 2of2
STERILE WATER
water injection
Product Information
Route of Administration 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 15mLIn1VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103960 05/01/1986
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103960 05/01/1986
Labeler -CSL Behring GmbH(326530474)
Establishment
Name Address ID/FEI Operations
CSL Behring GmbH 326530474 MANUFACTURE
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