Purple Book reference family · 351(a) biologic
Candida albicans Skin Test Antigen for Cellular Hypersensitivity (Candin)
Candida albicans Skin Test Antigen for Cellular Hypersensitivity is an FDA-licensed reference biologic from Nielsen Bioscience, Inc.
351(a) biologicBLA 103257 Nielsen Bioscience, Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1995
Reference product
Originator biologic
351(a)BLA 103257
Candin Candida albicans Skin Test Antigen for Cellular Hypersensitivity
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 Candida albicans Skin Test Antigen for Cellular Hypersensitivity product.
31 yr 1 mo ago
Candida albicans Skin Test Antigen for Cellular Hypersensitivity: 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 Candida albicans Skin Test Antigen for Cellular Hypersensitivity.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
