Purple Book reference family · 351(a) biologic
technetium 99m tc fanolesomab (NeutroSpec)
technetium 99m tc fanolesomab is an FDA-licensed reference biologic from Palatin Technologies, Inc..
351(a) biologicBLA 103928 Palatin Technologies, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2004
Reference product
Originator biologic
351(a)BLA 103928
NeutroSpec technetium 99m tc fanolesomab
Palatin Technologies, Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference technetium 99m tc fanolesomab product.
22 yr 5 mo ago
technetium 99m tc fanolesomab: 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 technetium 99m tc fanolesomab.
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.
