WAINUA
These highlights do not include all the information needed to use WAINUA safely and effectively. See full prescribing information for WAINUA.WAINUA™ (eplontersen) injection, for subcutaneous useInitial U.S. Approval: 2023
Approved
Approval ID
d7dcb847-71dd-4fff-82d0-d43a465fc096
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EPLONTERSEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-9400
Application NumberNDA217388
Product Classification
M
Marketing Category
C73594
G
Generic Name
EPLONTERSEN
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (7)
EPLONTERSENActive
Quantity: 45 mg in 45 mg
Code: 0GRZ0F5XJ6
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT