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FDA Purple Book · Reference family

Positive Skin Test Control-Histamine (Histatrol)

Positive Skin Test Control-Histamine is an FDA-licensed reference biologic from ALK-Abello, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1950

Reference approved

Reference product

351(a)BLA 103754

Histatrol Positive Skin Test Control-Histamine

ALK-Abello, Inc.

Approved
Sep 29, 1950
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Positive Skin Test Control-Histamine, in chronological order.

  1. Reference approval

    Approval date of the reference Positive Skin Test Control-Histamine product.

    76 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for Positive Skin Test Control-Histamine (Histatrol)?

No 351(k) biosimilars or interchangeable biosimilars referencing Positive Skin Test Control-Histamine are listed in the FDA Purple Book yet.

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