sulfate injection, solution
Product Information
Item Code (Source) NDC:20536-323
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vincristine Sulfate (Vincristine) Vincristine Sulfate 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Mannitol 500 mg in 5 mL
Sodium Hydroxide
Sulfuric Acid
Water
Packaging
Item Code Package Description
1 NDC:20536-323-01 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202497 01/14/2013
Part 2 of 3
SPHINGOMYELIN-CHOLESTEROL
cholesterol, citric acid monohydrate, sodium citrate, alcohol, and water injection, suspension, liposomal
Product Information
Item Code (Source) NDC:20536-324
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Cholesterol
Citric Acid Monohydrate
Sodium Citrate
Alcohol
Water
Packaging
Item Code Package Description
1 NDC:20536-324-01 1 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202497 01/14/2013
Part 3 of 3
SODIUM PHOSPHATE
sodium phosphate, dibasic, heptahydrate, sodium chloride, and water injection, solution
Product Information
Item Code (Source) NDC:20536-325
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Sodium Phosphate, Dibasic, Heptahydrate 14.2 mg in 1 mL
Sodium Chloride
Water
Packaging
Item Code Package Description
1 NDC:20536-325-01 25 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202497 01/14/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202497 01/14/2013
Labeler - Talon Therapeutics, Inc (147517044)
Establishment
Name Address ID/FEI Operations
Fine Chemicals (PTY) 568855923 API MANUFACTURE(20536-322), ANALYSIS(20536-322)
Establishment
Name Address ID/FEI Operations
Hospira Australia Pty Ltd 758967652 MANUFACTURE(20536-322), ANALYSIS(20536-322)
Establishment
Name Address ID/FEI Operations
Cangene 244844056 MANUFACTURE(20536-322), ANALYSIS(20536-322)
Establishment
Name Address ID/FEI Operations
Jubilant Hollister-Stier 069263643 MANUFACTURE(20536-322), ANALYSIS(20536-322)
Establishment
Name Address ID/FEI Operations
Nucro 241266845 ANALYSIS(20536-322)
Establishment
Name Address ID/FEI Operations
PPD Development, LP 838082055 ANALYSIS(20536-322)
Establishment
Name Address ID/FEI Operations
AndersonBrecon 053217022 LABEL(20536-322), PACK(20536-322)
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