Kynamro
Approved
Approval ID
774c7847-490b-41d5-9e0e-2baedbc94f62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2017
Manufacturers
FDA
Kastle Therapeutics, LLC
DUNS: 080134022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MIPOMERSEN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70688-0502
Application NumberNDA203568
Product Classification
M
Marketing Category
C73594
G
Generic Name
MIPOMERSEN SODIUM
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 17, 2017
FDA Product Classification
INGREDIENTS (4)
MIPOMERSEN SODIUMActive
Quantity: 200 mg in 1 mL
Code: 18EAY4870E
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT