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Bravelle

urofollitropin

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Bravelle
Proper name
urofollitropin
Licence type
351(a)
BLA number
021289
Applicant
Ferring Pharmaceuticals 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
75IU For Injection Subcutaneous, Intramuscular Single-Dose Vial Disc May 6, 2002

Sources for this page

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