FDA.reportPublic FDA data

Flebogamma 5%, Flebogamma 5% Dif Purple Book BLA 125077

BLA number
125077
Proprietary names
Flebogamma 5%, Flebogamma 5% Dif
Proper names
Immune Globulin Intravenous (Human)
Applicant
Instituto Grifols, S.A.
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
001Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)0.5G/10MLInjectionIntravenousSingle-Dose VialDiscLicensed2003-12-15
002Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)2.5G/50MLInjectionIntravenousSingle-Dose VialDiscLicensed2003-12-15
003Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)5G/100MLInjectionIntravenousSingle-Dose VialRxLicensed2003-12-15
004Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)10G/200MLInjectionIntravenousSingle-Dose VialRxLicensed2003-12-15
005Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)20G/400MLInjectionIntravenousSingle-Dose VialRxLicensed2006-12-21
006Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)5G/50MLInjectionIntravenousSingle-Dose VialDiscLicensed2010-07-27
007Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)10G/100MLInjectionIntravenousSingle-Dose VialDiscLicensed2010-07-27
008Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)20G/200MLInjectionIntravenousSingle-Dose VialDiscLicensed2010-07-27

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
2024-07-01U001Flebogamma 5%, Flebogamma 5% Dif351(a)DiscInstituto Grifols, S.A.
2024-07-01U002Flebogamma 5%, Flebogamma 5% Dif351(a)DiscInstituto Grifols, S.A.
2024-07-01U003Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2024-07-01U004Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2024-07-01U005Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2024-07-01U006Flebogamma 5%, Flebogamma 5% Dif351(a)DiscInstituto Grifols, S.A.
2024-07-01U007Flebogamma 5%, Flebogamma 5% Dif351(a)DiscInstituto Grifols, S.A.
2024-07-01U008Flebogamma 5%, Flebogamma 5% Dif351(a)DiscInstituto Grifols, S.A.
2023-06-01U001Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2023-06-01U002Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2023-06-01U003Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2022-01-01U001Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2022-01-01N003Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2021-05-01U001Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2021-05-01U002Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2020-08-01R001Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.
2020-08-01R002Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxInstituto Grifols, S.A.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2024-07-01001Flebogamma 5%, Flebogamma 5% Dif351(a)DiscLicensed2003-12-15
2024-07-01002Flebogamma 5%, Flebogamma 5% Dif351(a)DiscLicensed2003-12-15
2024-07-01003Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2003-12-15
2024-07-01004Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2003-12-15
2024-07-01005Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2006-12-21
2024-07-01006Flebogamma 5%, Flebogamma 5% Dif351(a)DiscLicensed2010-07-27
2024-07-01007Flebogamma 5%, Flebogamma 5% Dif351(a)DiscLicensed2010-07-27
2024-07-01008Flebogamma 5%, Flebogamma 5% Dif351(a)DiscLicensed2010-07-27
2023-06-01001Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2003-12-15
2023-06-01002Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2010-07-27
2023-06-01003Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2006-12-21
2022-01-01003Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2006-12-21
2020-08-01001Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2003-12-15
2020-08-01002Flebogamma, Flebogamma 5%, Flebogamma 5% Dif351(a)RxLicensed2010-07-27