KYNAMRO- mipomersen sodium injection, solution 
Kastle Therapeutics, LLC

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KYNAMRO- MIPOMERSEN SODIUM INJECTION, SOLUTION

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label

KYNAMRO 
mipomersen sodium injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70688-0502
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MIPOMERSEN SODIUM (UNII: 18EAY4870E) (MIPOMERSEN - UNII:9GJ8S4GU0M) MIPOMERSEN SODIUM200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70688-0502-11 in 1 CARTON05/02/2016
11 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:70688-0502-24 in 1 CARTON05/02/2016
21 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20356805/02/2016
Labeler - Kastle Therapeutics, LLC (080134022)
Establishment
NameAddressID/FEIBusiness Operations
Genzyme Corporation098066215MANUFACTURE(70688-0502) , ANALYSIS(70688-0502) , PACK(70688-0502) , LABEL(70688-0502)
Establishment
NameAddressID/FEIBusiness Operations
Genzyme Haverhill229522842PACK(70688-0502) , ANALYSIS(70688-0502) , LABEL(70688-0502)
Establishment
NameAddressID/FEIBusiness Operations
International Laboratory Services, Ltd777381963STERILIZE(70688-0502)
Establishment
NameAddressID/FEIBusiness Operations
Ionis Pharmaceuticals Inc.011829916API MANUFACTURE(70688-0502) , ANALYSIS(70688-0502)
Establishment
NameAddressID/FEIBusiness Operations
PCI Pharma Services053217022LABEL(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