hudquzco rubber panel,rubber panel t.r.u.e. test Purple Book BLA 125579

BLA number
125579
Proprietary names
hudquzco rubber panel,rubber panel t.r.u.e. test
Proper names
Rubber Panel 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
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001hudquzco rubber panel,rubber panel t.r.u.e. testRubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test351(a)PATCH TEST 5 ALLERGEN AND ALLERGEN MIX PATCHES AND A NEGATIVE CONTROL.PatchTopicalBlister PackRxLicensed2017-03-03

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
ReleaseEventProductNameLicense typeStatusApplicant
2025-12-01U001hudquzco rubber panel,rubber panel t.r.u.e. test351(a)RxSmartPractice Denmark ApS
2021-05-01U001Rubber Panel T.R.U.E. Test351(a)RxSmartPractice Denmark ApS
2020-08-01R001Rubber Panel T.R.U.E. Test351(a)RxSmartPractice Denmark ApS

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2025-12-01001hudquzco rubber panel,rubber panel t.r.u.e. test351(a)RxLicensed2017-03-03
2020-08-01001Rubber Panel T.R.U.E. Test351(a)RxLicensed2017-03-03