Skip to content

On this page

Kalbitor

ecallantide

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kalbitor

Proper name

ecallantide

Licence type

351(a)

BLA number

125277

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CDER

Presentations

1

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/ML	Injection	Subcutaneous	Single-Dose Vial	Rx	December 1, 2009

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 28, 2021

Sources for this page

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