AMONDYS 45
These highlights do not include all the information needed to use AMONDYS 45 safely and effectively. See full prescribing information for AMONDYS 45. AMONDYS 45 (casimersen) injection, for intravenous useInitial U.S. Approval: 2021
Approved
Approval ID
e9e5fd44-eeda-4580-bba1-a734828bbcc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2023
Manufacturers
FDA
Sarepta Therapeutics, Inc.
DUNS: 121653406
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
casimersen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60923-227
Application NumberNDA213026
Product Classification
M
Marketing Category
C73594
G
Generic Name
casimersen
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 23, 2023
FDA Product Classification
INGREDIENTS (8)
casimersenActive
Quantity: 50 mg in 1 mL
Code: X8UHF7SX0R
Classification: ACTIB
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
potassium phosphate, monobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT