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Zenpep

pancrelipase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Zenpep

Proper name

pancrelipase

Licence type

351(a)

BLA number

022210

Applicant

Aimmune Therapeutics, Inc.

Center

CDER

Presentations

8

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
10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	August 27, 2009
15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	August 27, 2009
20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	August 27, 2009
25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	July 13, 2011
3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	June 15, 2011
40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	March 25, 2014
5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS	Capsule, Delayed Release	Oral	—	Rx	August 27, 2009
60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS	Capsule, Delayed Release	Oral	—	Rx	October 27, 2023

Sources for this page

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