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
NDC Product Code70688-0502
Application NumberNDA203568
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 17, 2017
Generic NameMIPOMERSEN SODIUM
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