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Creon

pancrelipase

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Creon
Proper name
pancrelipase
Licence type
351(a)
BLA number
020725
Applicant
AbbVie Inc.
Center
CDER
Presentations
5
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
12,000USP UNITS; 38,000USP UNITS; 60,000USP UNITS Capsule, Delayed Release Oral — Rx April 30, 2009
24,000USP UNITS; 76,000USP UNITS; 120,000USP UNITS Capsule, Delayed Release Oral — Rx April 30, 2009
3,000USP UNITS; 9,500USP UNITS; 15,000USP UNITS Capsule, Delayed Release Oral — Rx June 10, 2011
36,000USP UNITS; 114,000USP UNITS; 180,000USP UNITS Capsule, Delayed Release Oral — Rx March 14, 2013
6,000USP UNITS; 19,000USP UNITS; 30,000USP UNITS Capsule, Delayed Release Oral — Rx April 30, 2009

Sources for this page

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