Purple Book reference family · 351(a) biologic
Positive Skin Test Control-Histamine (Histatrol)
Positive Skin Test Control-Histamine is an FDA-licensed reference biologic from ALK-Abello, Inc..
351(a) biologicBLA 103754 ALK-Abello, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1950
Reference product
Originator biologic
351(a)BLA 103754
Histatrol Positive Skin Test Control-Histamine
ALK-Abello, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Positive Skin Test Control-Histamine product.
76 yr 11 mo ago
Positive Skin Test Control-Histamine: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Positive Skin Test Control-Histamine.
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