Purple Book reference family · 351(a) biologic
Immune Globulin Intravenous (Human)-ifas (Panzyga)
Immune Globulin Intravenous (Human)-ifas is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H..
351(a) biologicBLA 125587 Octapharma Pharmazeutika Produktionsges.m.b.H.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018
Reference product
Originator biologic
351(a)BLA 125587
Panzyga Immune Globulin Intravenous (Human)-ifas
Octapharma Pharmazeutika Produktionsges.m.b.H.
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 Immune Globulin Intravenous (Human)-ifas product.
8 yr 1 mo ago
Immune Globulin Intravenous (Human)-ifas: 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 Immune Globulin Intravenous (Human)-ifas.
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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.
