Purple Book reference family · 351(a) biologic
Vaccinia Immune Globulin Intravenous (Human) (Cnj-016)
Vaccinia Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from Emergent BioSolutions Canada Inc..
351(a) biologicBLA 125109 Emergent BioSolutions Canada Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2005
Reference product
Originator biologic
351(a)BLA 125109
Cnj-016 Vaccinia Immune Globulin Intravenous (Human)
Emergent BioSolutions Canada 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 Vaccinia Immune Globulin Intravenous (Human) product.
21 yr 7 mo ago
Vaccinia Immune Globulin Intravenous (Human): 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 Vaccinia Immune Globulin Intravenous (Human).
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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.
