Purple Book reference family · 351(a) biologic
Thin-Layer Rapid Use Epicutaneous Patch Test (T.R.U.E. Test)
Thin-Layer Rapid Use Epicutaneous Patch Test is an FDA-licensed reference biologic from SmartPractice Denmark ApS.
351(a) biologicBLA 103738 SmartPractice Denmark ApS
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1997
Reference product
Originator biologic
351(a)BLA 103738
T.R.U.E. Test Thin-Layer Rapid Use Epicutaneous Patch Test
SmartPractice Denmark ApS
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 Thin-Layer Rapid Use Epicutaneous Patch Test product.
29 yr 4 mo ago
Thin-Layer Rapid Use Epicutaneous Patch Test: 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 Thin-Layer Rapid Use Epicutaneous Patch Test.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
