Purple Book reference family · 351(a) biologic
Rho(D) Immune Globulin Intravenous (Human) (Rhophylac)
Rho(D) Immune Globulin Intravenous (Human) is an FDA-licensed reference biologic from CSL Behring AG.
351(a) biologicBLA 125070 CSL Behring AG
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2004
Reference product
Originator biologic
351(a)BLA 125070
Rhophylac Rho(D) Immune Globulin Intravenous (Human)
CSL Behring AG
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 Rho(D) Immune Globulin Intravenous (Human) product.
22 yr 11 mo ago
Rho(D) 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 Rho(D) Immune Globulin Intravenous (Human).
Related FDA reference tools
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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.
