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Aplisol
Tuberculin, Purified Protein Derivative
351(a) Standalone BLA
Overview
Source: Purple BookProprietary 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| 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 |