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Cotazym

pancrelipase

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Cotazym
Proper name
pancrelipase
Licence type
351(a)
BLA number
020580
Applicant
Organon USA Inc., a subsidiary of Merck & Co., Inc.
Center
CDER
Presentations
1
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
8,000USP UNITS; 30,000USP UNITS; 30,000USP UNITS Capsule, Delayed Release Oral — Disc December 9, 1996

Sources for this page

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