WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69794-304-01 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 04/18/2018
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761068 04/18/2018
CRYSVITA
burosumab injection
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69794-203
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
BUROSUMAB (UNII: G9WJT6RD29) (BUROSUMAB - UNII:G9WJT6RD29) BUROSUMAB 20 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R) 45.91 mg in 1 mL
HISTIDINE (UNII: 4QD397987E) 1.55 mg in 1 mL
METHIONINE (UNII: AE28F7PNPL) 1.49 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.50 mg in 1 mL
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69794-203-01 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 04/18/2018
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761068 04/18/2018
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