FDA.reportPublic FDA data

Hizentra Purple Book BLA 125350

BLA number
125350
Proprietary names
Hizentra
Proper names
Immune Globulin Subcutaneous (Human), 20% Liquid
Applicant
CSL Behring AG
Center
CBER
First observed release
2020-08-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)2G/10MLInjectionSubcutaneousSingle-Dose VialRxLicensed2010-03-04
002HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)1G/5MLInjectionSubcutaneousSingle-Dose VialRxLicensed2010-03-04
003HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)10G/50MLInjectionSubcutaneousSingle-Dose VialRxLicensed2010-03-04
004HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)4G/20MLInjectionSubcutaneousSingle-Dose VialRxLicensed2010-03-04
005HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)1G/5MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-04-13
006HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)2G/10MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-04-13
007HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)4G/20MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-04-13
008HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)10G/50MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-04-13

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2026-06-01U005Hizentra351(a)RxCSL Behring AG
2026-06-01U006Hizentra351(a)RxCSL Behring AG
2026-06-01U007Hizentra351(a)RxCSL Behring AG
2026-06-01U008Hizentra351(a)RxCSL Behring AG
2024-07-01U001Hizentra351(a)RxCSL Behring AG
2024-07-01U002Hizentra351(a)RxCSL Behring AG
2024-07-01U003Hizentra351(a)RxCSL Behring AG
2024-07-01U004Hizentra351(a)RxCSL Behring AG
2024-07-01N005Hizentra351(a)RxCSL Behring AG
2021-09-01U001Hizentra351(a)RxCSL Behring AG
2021-09-01U002Hizentra351(a)RxCSL Behring AG
2021-09-01U003Hizentra351(a)RxCSL Behring AG
2021-09-01U004Hizentra351(a)RxCSL Behring AG
2021-05-01U001Hizentra351(a)RxCSL Behring AG
2021-05-01U002Hizentra351(a)RxCSL Behring AG
2021-05-01U003Hizentra351(a)RxCSL Behring AG
2021-05-01U004Hizentra351(a)RxCSL Behring AG
2020-08-01R001Hizentra351(a)RxCSL Behring AG
2020-08-01R002Hizentra351(a)RxCSL Behring AG
2020-08-01R003Hizentra351(a)RxCSL Behring AG
2020-08-01R004Hizentra351(a)RxCSL Behring AG

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2026-06-01006Hizentra351(a)RxLicensed2023-04-13
2026-06-01007Hizentra351(a)RxLicensed2023-04-13
2026-06-01008Hizentra351(a)RxLicensed2023-04-13
2024-07-01005Hizentra351(a)RxLicensed2023-04-13
2020-08-01001Hizentra351(a)RxLicensed2010-03-04
2020-08-01002Hizentra351(a)RxLicensed2010-03-04
2020-08-01003Hizentra351(a)RxLicensed2010-03-04
2020-08-01004Hizentra351(a)RxLicensed2010-03-04