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Ngenla

somatrogon-ghla

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ngenla

Proper name

somatrogon-ghla

Licence type

351(a)

BLA number

761184

Applicant

Pfizer Ireland Pharmaceuticals Unlimited Company

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
24MG/1.2ML (20MG/ML)	Injection	Subcutaneous	Autoinjector	Rx	June 27, 2023
60MG/1.2ML (50MG/ML)	Injection	Subcutaneous	Autoinjector	Rx	June 27, 2023

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	June 27, 2030

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity