Label: KYNAMRO- mipomersen sodium injection, solution

  • NDC Code(s): 70688-0502-1, 70688-0502-2
  • Packager: Kastle Therapeutics, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated January 17, 2017

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  • SPL UNCLASSIFIED SECTION

    KYNAMRO- MIPOMERSEN SODIUM INJECTION, SOLUTION

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  • INGREDIENTS AND APPEARANCE
    KYNAMRO 
    mipomersen sodium injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70688-0502
    Route of Administration SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MIPOMERSEN SODIUM (UNII: 18EAY4870E) (MIPOMERSEN - UNII:9GJ8S4GU0M) MIPOMERSEN SODIUM 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70688-0502-1 1 in 1 CARTON 05/02/2016
    1 1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2 NDC:70688-0502-2 4 in 1 CARTON 05/02/2016
    2 1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA203568 05/02/2016
    Labeler - Kastle Therapeutics, LLC (080134022)
    Establishment
    Name Address ID/FEI Business Operations
    Genzyme Corporation 098066215 MANUFACTURE(70688-0502) , ANALYSIS(70688-0502) , PACK(70688-0502) , LABEL(70688-0502)
    Establishment
    Name Address ID/FEI Business Operations
    Genzyme Haverhill 229522842 PACK(70688-0502) , ANALYSIS(70688-0502) , LABEL(70688-0502)
    Establishment
    Name Address ID/FEI Business Operations
    International Laboratory Services, Ltd 777381963 STERILIZE(70688-0502)
    Establishment
    Name Address ID/FEI Business Operations
    Ionis Pharmaceuticals Inc. 011829916 API MANUFACTURE(70688-0502) , ANALYSIS(70688-0502)
    Establishment
    Name Address ID/FEI Business Operations
    PCI Pharma Services 053217022 LABEL(70688-0502) , PACK(70688-0502)
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