Label: KYNAMRO- mipomersen sodium injection, solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70688-0502-1, 70688-0502-2 - Packager: Kastle Therapeutics, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 17, 2017
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INGREDIENTS AND APPEARANCE
KYNAMRO
mipomersen sodium injection, solutionProduct 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)
