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Aplisol

Tuberculin, Purified Protein Derivative

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Aplisol
Proper name
Tuberculin, Purified Protein Derivative
Licence type
351(a)
BLA number
103782
Applicant
Endo Operations Limited
Center
CBER
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
5TU/.1ML Injection Intradermal Multi-Dose Vial Rx April 20, 1998

Sources for this page

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