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Emgality
galcanezumab-gnlm
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Emgality
Proper name
galcanezumab-gnlm
Licence type
351(a)
BLA number
761063
Applicant
Eli Lilly and Company
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 4, 2019 |
| 120MG/ML | Injection | Subcutaneous | Autoinjector | Rx | September 27, 2018 |
| 120MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | September 27, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |