FDA.reportPublic FDA data

Hepagam B Purple Book BLA 125237

This BLA is retained from the historical Purple Book archive and was not present in the newest imported release. FDA.report does not infer a regulatory status from that absence.

BLA number
125237
Proprietary names
Hepagam B
Proper names
Hepatitis B Immune Globulin Intravenous (Human)
Applicant
Kamada Ltd.
Center
CBER
First observed release
2020-08-01
Latest observed release
2024-12-01
Newest archive release
2024-12-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Historical archive only

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Hepagam BHepatitis B Immune Globulin Intravenous (Human)351(a)>312IU/MLInjectionIntravenousVialRxLicensed2007-04-06
002Hepagam BHepatitis B Immune Globulin Intravenous (Human)351(a)>1560IU/5MLInjectionIntravenousVialRxLicensed2007-04-06

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
2023-07-01U001Hepagam B351(a)RxKamada Ltd.
2023-07-01N002Hepagam B351(a)RxKamada Ltd.
2023-06-01U001Hepagam B351(a)DiscKamada Ltd.
2022-09-01U001Hepagam Bt351(a)DiscKamada Ltd.
2022-01-01U001Hepagam Bt351(a)DiscSaol Therapeutics Research Limited
2021-05-01U001Hepagam Bt351(a)DiscSaol Therapeuctics Research Limited
2020-08-01R001Hepagam Bt351(a)DiscSaol Therapeuctics Research Limited

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2023-07-01001Hepagam B351(a)RxLicensed2007-04-06
2023-07-01002Hepagam B351(a)RxLicensed2007-04-06
2023-06-01001Hepagam B351(a)DiscLicensed2007-04-06
2020-08-01001Hepagam Bt351(a)DiscLicensed2007-04-06