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Humatrope

somatropin

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Humatrope

Proper name

somatropin

Licence type

351(a)

BLA number

019640

Applicant

Eli Lilly and Company

Center

CDER

Presentations

5

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
12MG	For Injection	Subcutaneous	Multi-Dose Cartridge	Rx	February 4, 1999
24MG	For Injection	Subcutaneous	Multi-Dose Cartridge	Rx	February 4, 1999
2MG	For Injection	Subcutaneous	Single-Dose Vial	Disc	June 23, 1987
5MG	For Injection	Subcutaneous	Single-Dose Vial	Disc	October 16, 1986
6MG	For Injection	Subcutaneous	Multi-Dose Cartridge	Rx	February 4, 1999

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 1, 2013

Sources for this page

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