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Zomacton

somatropin

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Zomacton

Proper name

somatropin

Licence type

351(a)

BLA number

019774

Applicant

Ferring Pharmaceuticals Inc.

Center

CDER

Presentations

3

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
10MG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	March 7, 2012
4.8MG	For Injection	Subcutaneous	Multi-Dose Vial	Disc	May 25, 1995
5MG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	January 4, 2002

Sources for this page

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