SAPHNELO
These highlights do not include all the information needed to use SAPHNELO safely and effectively. See full prescribing information for SAPHNELO.SAPHNELO (anifrolumab-fnia) injection, for intravenous useInitial U.S. Approval: 2021
Approved
Approval ID
d6203302-2128-41a7-b0b4-0e6c0704d4dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 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.
Anifrolumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-3040
Application NumberBLA761123
Product Classification
M
Marketing Category
C73585
G
Generic Name
Anifrolumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 30, 2021
FDA Product Classification
INGREDIENTS (7)
ANIFROLUMABActive
Quantity: 300 mg in 2.0 mL
Code: 38RL9AE51Q
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 6 mg in 2.0 mL
Code: X573657P6P
Classification: IACT
HISTIDINEInactive
Quantity: 3 mg in 2.0 mL
Code: 4QD397987E
Classification: IACT
LYSINE HYDROCHLORIDEInactive
Quantity: 18 mg in 2.0 mL
Code: JNJ23Q2COM
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 98 mg in 2.0 mL
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 1 mg in 2.0 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT