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FDA Purple Book · Reference family

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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1997

Reference approved

Reference product

351(a)BLA 103738

T.R.U.E. Test Thin-Layer Rapid Use Epicutaneous Patch Test

SmartPractice Denmark ApS

Approved
Aug 15, 1997
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Thin-Layer Rapid Use Epicutaneous Patch Test, in chronological order.

  1. Reference approval

    Approval date of the reference Thin-Layer Rapid Use Epicutaneous Patch Test product.

    29 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for Thin-Layer Rapid Use Epicutaneous Patch Test (T.R.U.E. Test)?

No 351(k) biosimilars or interchangeable biosimilars referencing Thin-Layer Rapid Use Epicutaneous Patch Test are listed in the FDA Purple Book yet.

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