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Pancreaze

pancrelipase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Pancreaze

Proper name

pancrelipase

Licence type

351(a)

BLA number

022523

Applicant

VIVUS LLC

Center

CDER

Presentations

6

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
10,500USP UNITS; 35,500USP UNITS; 61,500USP UNITS	Capsule, Delayed Release	Oral	—	Rx	April 12, 2010
16,800USP UNITS; 56,800USP UNITS; 98,400USP UNITS	Capsule, Delayed Release	Oral	—	Rx	April 12, 2010
2,600USP UNITS; 8,800USP UNITS; 15,200USP UNITS	Capsule, Delayed Release	Oral	—	Rx	March 7, 2014
21,000USP UNITS; 54,700USP UNITS; 83,900USP UNITS	Capsule, Delayed Release	Oral	—	Rx	April 12, 2010
37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS	Capsule, Delayed Release	Oral	—	Rx	April 26, 2021
4,200USP UNITS; 14,200USP UNITS; 24,600USP UNITS	Capsule, Delayed Release	Oral	—	Rx	April 12, 2010

Sources for this page

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