Purple Book reference family · 351(a) biologic
Pooled Plasma (Human), Solvent/Detergent Treated (Octaplas)
Pooled Plasma (Human), Solvent/Detergent Treated is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H..
351(a) biologicBLA 125416 Octapharma Pharmazeutika Produktionsges.m.b.H.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2013
Reference product
Originator biologic
351(a)BLA 125416
Octaplas Pooled Plasma (Human), Solvent/Detergent Treated
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 Pooled Plasma (Human), Solvent/Detergent Treated product.
13 yr 9 mo ago
Pooled Plasma (Human), Solvent/Detergent Treated: 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 Pooled Plasma (Human), Solvent/Detergent Treated.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
