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Vitrase

hyaluronidase

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Vitrase
Proper name
hyaluronidase
Licence type
351(a)
BLA number
021640
Applicant
Bausch & Lomb Incorporated
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
200UNITS/ML Injection Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous Single-Dose Vial Rx December 2, 2004
6,200UNITS/ML Injection Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous Single-Dose Vial Disc May 5, 2004

Sources for this page

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