KYNAMRO- mipomersen sodium injection, solution 
Kastle Therapeutics, LLC

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KYNAMRO- MIPOMERSEN SODIUM INJECTION, SOLUTION

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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)

Revised: 1/2017
Document Id: 900bb03a-deb5-4522-8dc1-755994b073b6
Set id: 774c7847-490b-41d5-9e0e-2baedbc94f62
Version: 2
Effective Time: 20170117
 
Kastle Therapeutics, LLC