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Viokace

pancrelipase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Viokace

Proper name

pancrelipase

Licence type

351(a)

BLA number

022542

Applicant

Viokace, LLC

Center

CDER

Presentations

2

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
10,440USP UNITS; 39,150USP UNITS; 39,150USP UNITS	Tablet	Oral	—	Rx	March 1, 2012
20,880USP UNITS; 78,300USP UNITS; 78,300USP UNITS	Tablet	Oral	—	Rx	March 1, 2012

Sources for this page

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