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Nutropin AQ

somatropin

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Nutropin AQ
Proper name
somatropin
Licence type
351(a)
BLA number
020522
Applicant
Genentech, Inc.
Center
CDER
Presentations
6
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/2ML Injection Subcutaneous Vial Disc December 29, 1995
10MG/2ML Injection Subcutaneous Multi-Dose Cartridge Disc April 22, 2002
10MG/2ML Injection Subcutaneous Autoinjector Disc January 3, 2008
20MG/2ML Injection Subcutaneous Autoinjector Disc January 3, 2008
20MG/2ML Injection Subcutaneous Multi-Dose Cartridge Disc January 3, 2008
5MG/2ML Injection Subcutaneous Autoinjector Disc January 3, 2008

Sources for this page

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