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T.R.U.E. Test

Thin-Layer Rapid Use Epicutaneous Patch Test

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

T.R.U.E. Test

Proper name

Thin-Layer Rapid Use Epicutaneous Patch Test

Licence type

351(a)

BLA number

103738

Applicant

SmartPractice Denmark ApS

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
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	August 15, 1997

Purple Book	FDA	Licence type, presentations, reference product, exclusivity