Purple Book reference family · 351(a) biologic
Tuberculin, Purified Protein Derivative (Aplisol)
Tuberculin, Purified Protein Derivative is an FDA-licensed reference biologic from Endo Operations Limited.
351(a) biologicBLA 103782 Endo Operations Limited
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1998
Reference product
Originator biologic
351(a)BLA 103782
Aplisol Tuberculin, Purified Protein Derivative
Endo Operations Limited
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Tuberculin, Purified Protein Derivative product.
28 yr 8 mo ago
Tuberculin, Purified Protein Derivative: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Tuberculin, Purified Protein Derivative.
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