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Siliq

These highlights do not include all the information needed to use SILIQ safely and effectively. See full prescribing information for SILIQ. SILIQ (brodalumab) injection, for subcutaneous use Initial U.S. Approval: 2017

Approved
Approval ID

1a550c33-456a-4833-814e-8591aea7c688

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2023

Manufacturers
FDA

Bausch Health US LLC

DUNS: 831922468

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Brodalumab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0187-0004
Application NumberBLA761032
Product Classification
M
Marketing Category
C73585
G
Generic Name
Brodalumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 1, 2023
FDA Product Classification

INGREDIENTS (1)

BRODALUMABActive
Quantity: 210 mg in 1 1
Code: 6ZA31Y954Z
Classification: ACTIB

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Siliq - FDA Drug Approval Details