Purple Book reference family · 351(a) biologic
Coccidioides immitis Spherule-Derived Skin Test Antigen (Spherusol)
Coccidioides immitis Spherule-Derived Skin Test Antigen is an FDA-licensed reference biologic from Nielsen Bioscience, Inc.
351(a) biologicBLA 125354 Nielsen Bioscience, Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011
Reference product
Originator biologic
351(a)BLA 125354
Spherusol Coccidioides immitis Spherule-Derived Skin Test Antigen
Nielsen Bioscience, 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 Coccidioides immitis Spherule-Derived Skin Test Antigen product.
15 yr 3 mo ago
Coccidioides immitis Spherule-Derived Skin Test Antigen: 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 Coccidioides immitis Spherule-Derived Skin Test Antigen.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
