Product Details for: Xolair

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
150MG
Single-Dose Vial
351(a)
Xolair
Rx
002
Injection
Subcutaneous
75MG/0.5ML
Pre-Filled Syringe
351(a)
Xolair
Rx
003
Injection
Subcutaneous
150MG/ML
Pre-Filled Syringe
351(a)
Xolair
Rx
004
Injection
Subcutaneous
300MG/2ML
Pre-Filled Syringe
351(a)
Xolair
Rx
005
Injection
Subcutaneous
75MG/0.5ML
Autoinjector
351(a)
Xolair
Rx
006
Injection
Subcutaneous
150MG/ML
Autoinjector
351(a)
Xolair
Rx
007
Injection
Subcutaneous
300MG/2ML
Autoinjector
351(a)
Xolair
Rx
Proper Name
omalizumab
BLA Number
103976
Applicant
Genentech, Inc.
Original Approval Date
June 20, 2003
Date of First Licensure
Patent List Provided
Yes
RETURN TO SEARCH RESULTS