Product Details for: Ngenla
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
24MG/1.2ML (20MG/ML)
Autoinjector
351(a)
Ngenla
Rx
002
Injection
Subcutaneous
60MG/1.2ML (50MG/ML)
Autoinjector
351(a)
Ngenla
Rx
Proper Name
somatrogon-ghla
somatrogon-ghla
BLA Number
761184
761184
Applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Pfizer Ireland Pharmaceuticals Unlimited Company
Original Approval Date
June 27, 2023
June 27, 2023
Date of First Licensure