t Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61126-004
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cisplatin (cisplatin) cisplatin 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Hydrochloric Acid
Sodium Hydroxide
Water
Packaging
# Item Code Package Description
1 NDC:61126-004-01 1 in 1 CARTON
1 50 mL in 1 VIAL, MULTI-DOSE
2 NDC:61126-004-02 1 in 1 CARTON
2 100 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018057 01/13/2012
Labeler - Corden Pharma Latina S.p.A. (339062883)
Establishment
Name Address ID/FEI Business Operations
Corden Pharma Latina S.p.A. 339062883 MANUFACTURE
Revised: 01/2012 |
