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Repronex

menotropins

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Repronex
Proper name
menotropins
Licence type
351(a)
BLA number
021047
Applicant
Ferring Pharmaceuticals Inc.
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
150IU For Injection Subcutaneous, Intramuscular Single-Dose Vial Disc August 27, 1999
75IU For Injection Subcutaneous, Intramuscular Single-Dose Vial Disc August 27, 1999

Sources for this page

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