Purple Book reference family · 351(a) biologic
Poliovirus Vaccine Inactivated (Human Diploid Cell) (Poliovax)
Poliovirus Vaccine Inactivated (Human Diploid Cell) is an FDA-licensed reference biologic from Sanofi Vaccines Canada Ltd..
351(a) biologicBLA 103940 Sanofi Vaccines Canada Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 103940
Poliovax Poliovirus Vaccine Inactivated (Human Diploid Cell)
Sanofi Vaccines Canada Ltd.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Poliovirus Vaccine Inactivated (Human Diploid Cell) product.
26 yr 10 mo ago
Poliovirus Vaccine Inactivated (Human Diploid Cell): 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 Poliovirus Vaccine Inactivated (Human Diploid Cell).
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- 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.
