Gamimune Purple Book BLA 101147

BLA number: 101147
Proprietary names: Gamimune
Proper names: Immune Globulin Intravenous (Human)
Applicant: Grifols Therapeutics LLC
Center: CBER
First observed release: 2022-05-01
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
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Gamimune	Immune Globulin Intravenous (Human)	351(a)	5PCT	Injection	Intravenous	Vial	Disc	Voluntarily Revoked	1981-09-11
002	Gamimune	Immune Globulin Intravenous (Human)	351(a)	10PCT	Injection	Intravenous	Vial	Disc	Voluntarily Revoked	1981-09-11

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
Release	Event	Product	Name	License type	Status	Applicant
2023-07-01	U	001	Gamimune	351(a)	Disc	Grifols Therapeutics LLC
2023-07-01	U	002	Gamimune	351(a)	Disc	Grifols Therapeutics LLC
2022-05-01	N	001	Gamimune	351(a)	Rx	Grifols Therapeutics LLC
2022-05-01	N	002	Gamimune	351(a)	Rx	Grifols Therapeutics LLC

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2023-07-01	001	Gamimune	351(a)	Disc	Voluntarily Revoked	1981-09-11
2023-07-01	002	Gamimune	351(a)	Disc	Voluntarily Revoked	1981-09-11
2022-05-01	001	Gamimune	351(a)	Rx	Voluntarily Revoked	1981-09-11
2022-05-01	002	Gamimune	351(a)	Rx	Voluntarily Revoked	1981-09-11