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Pertzye

pancrelipase

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Pertzye
Proper name
pancrelipase
Licence type
351(a)
BLA number
022175
Applicant
Digestive Care, Inc.
Center
CDER
Presentations
4
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
16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS Capsule, Delayed Release Oral — Rx May 17, 2012
24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS Capsule, Delayed Release Oral — Rx July 13, 2017
4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS Capsule, Delayed Release Oral — Rx October 6, 2016
8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS Capsule, Delayed Release Oral — Rx May 17, 2012

Sources for this page

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