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Trulicity

dulaglutide

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Trulicity
Proper name
dulaglutide
Licence type
351(a)
BLA number
125469
Applicant
Eli Lilly and Company
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
0.75MG/0.5ML Injection Subcutaneous Autoinjector Rx September 18, 2014
0.75MG/0.5ML Injection Subcutaneous Pre-Filled Syringe Disc September 18, 2014
1.5MG/0.5ML Injection Subcutaneous Autoinjector Rx September 18, 2014
1.5MG/0.5ML Injection Subcutaneous Pre-Filled Syringe Disc September 18, 2014
3MG/0.5ML Injection Subcutaneous Autoinjector Rx September 4, 2020
4.5MG/0.5ML Injection Subcutaneous Autoinjector Rx September 4, 2020

Sources for this page

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