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Myxredlin

insulin human

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Myxredlin

Proper name

insulin human

Licence type

351(a)

BLA number

208157

Applicant

Baxter Healthcare Corporation

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
100UNITS/100ML (1UNIT/ML)	Injection	Intravenous	Single-Dose Container	Rx	June 20, 2019

Sources for this page

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