Home PurpleBook 103738 T.R.U.E. Test Purple Book BLA 103738
BLA number 103738
Proprietary names T.R.U.E. Test
Proper names Thin-Layer Rapid Use Epicutaneous Patch Test
Applicant SmartPractice Denmark ApS
Center CBER
First observed release 2020-08-01
Latest observed release 2026-06-01
Newest archive release 2026-06-01
FDA patent list No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage Present in newest release Latest Known Product Presentations# Product, Proprietary name, Proper name table Product Proprietary name Proper name License type Strength Dosage form Route Presentation Marketing Licensure Approval Patent list provided 001 T.R.U.E. Test Thin-Layer Rapid Use Epicutaneous Patch Test 351(a) 36 MCG NICKEL/PATCH, 810 MCG WOOL ALCOHOL/PATCH, 486 MCG NEOMYCIN SULFATE/PATCH, 15.7 MCG CHROMIUM/PATCH, 510 MCG CAINE MIX/PATCH, 405 MCG FRAGRANCE MIX/PATCH, 972 MCG COLOPHONY/PATCH, 810 MCG PARABEN/PATCH, 648 MCG OF BALSAM OF PERU RESIN/PATCH, 18 MCG E Patch Topical Pouch Rx Licensed 1997-08-15
Published Patent List# No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2021-05-01 U 001 T.R.U.E. Test 351(a) Rx SmartPractice Denmark ApS 2020-08-01 R 001 T.R.U.E. Test 351(a) Rx SmartPractice Denmark ApS
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2020-08-01 001 T.R.U.E. Test 351(a) Rx Licensed 1997-08-15
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