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FDA Approval

Siliq

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Bausch Health US LLC
DUNS: 831922468
Effective Date
September 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Brodalumab(210 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Patheon Italia S.p.A.

Bausch Health US LLC

338336589

Products1

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

Siliq

Product Details

NDC Product Code
0187-0004
Application Number
BLA761032
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS
Effective Date
September 1, 2023
Code: 6ZA31Y954ZClass: ACTIBQuantity: 210 mg in 1 1
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