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Xolair
omalizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Xolair
Proper name
omalizumab
Licence type
351(a)
BLA number
103976
Applicant
Genentech, Inc.
Center
CDER
Presentations
7
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | June 20, 2003 |
| 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | September 28, 2018 |
| 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | August 17, 2023 |
| 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 17, 2023 |
| 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | August 17, 2023 |
| 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | September 28, 2018 |
| 75MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | August 17, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |