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Chymodiactin

chymopapain

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Chymodiactin
Proper name
chymopapain
Licence type
351(a)
BLA number
018663
Applicant
DisCure Medical, LLC
Center
CDER
Presentations
2
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
10,000UNITS For Injection Intrathecal Single-Dose Vial Disc November 10, 1982
4,000UNITS For Injection Intrathecal Single-Dose Vial Disc August 21, 1984

Sources for this page

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