Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized Purple Book BLA 103649

BLA number: 103649
Proprietary names: Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized
Proper names: Rho(D) Immune Globulin Intravenous (Human)
Applicant: Kamada Ltd.
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
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval
001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	5000IU	For Injection	Intramuscular	Vial	Disc	Licensed	1996-04-02
002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	5000IU	For Injection	Intravenous	Vial	Disc	Licensed	1996-04-02
003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	1500IU	For Injection	Intramuscular	Vial	Disc	Licensed	1996-04-02
004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	1500IU	For Injection	Intravenous	Vial	Disc	Licensed	1996-04-02
005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	600IU	For Injection	Intramuscular	Vial	Disc	Licensed	1996-04-02
006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	600IU	For Injection	Intravenous	Vial	Disc	Licensed	1996-04-02
007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	15000IU	Injection	Intramuscular	Vial	Disc	Licensed	2005-03-31
008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	15000IU	Injection	Intravenous	Vial	Disc	Licensed	2005-03-31
009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	5000IU	Injection	Intramuscular	Vial	Disc	Licensed	2005-03-31
010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	5000IU	Injection	Intravenous	Vial	Disc	Licensed	2005-03-31
011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	2500IU	Injection	Intramuscular	Vial	Disc	Licensed	2005-03-31
012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	2500IU	Injection	Intravenous	Vial	Disc	Licensed	2005-03-31
013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	1500IU	Injection	Intramuscular	Vial	Rx	Licensed	2005-03-31
014	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	1500IU	Injection	Intravenous	Vial	Rx	Licensed	2005-03-31
015	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	600IU	Injection	Intramuscular	Vial	Disc	Licensed	2005-03-31
016	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	600IU	Injection	Intravenous	Vial	Disc	Licensed	2005-03-31
017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	15000IU	Injection	Intravenous	Vial	Disc	Licensed	2015-12-18
018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	15000IU	Injection	Intramuscular	Vial	Disc	Licensed	2015-12-18

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.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
49591-330	WinRho SDF	HUMAN RHO(D) IMMUNE GLOBULIN	Kamada Ltd.	current
49591-350	WinRho SDF	HUMAN RHO(D) IMMUNE GLOBULIN	Kamada Ltd.	current
70257-300	WinRho SDF	rho (d) immune globulin	Saol Therapeutics Inc.	legacy
70257-310	WinRho SDF	rho (d) immune globulin	Saol Therapeutics Inc.	legacy
70257-330	WinRho SDF	rho (d) immune globulin	Saol Therapeutics Inc.	legacy
70257-350	WinRho SDF	rho (d) immune globulin	Saol Therapeutics Inc.	legacy
70504-3000	WINRHO	rho (d) immune globulin	Aptevo BioTherapeutics LLC	legacy
70504-3100	WINRHO	rho (d) immune globulin	Aptevo BioTherapeutics LLC	legacy
70504-3300	WINRHO	rho (d) immune globulin	Aptevo BioTherapeutics LLC	legacy
70504-3500	WINRHO	rho (d) immune globulin	Aptevo BioTherapeutics LLC	legacy

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
WinRho SDF	Kamada Ltd.	2026-04-16
WinRho SDF	Kamada Ltd.	2026-03-02
WinRho SDF	Saol Therapeutics Inc. \| Kamada Ltd.	2024-09-06
WINRHO	Aptevo BioTherapeutics LLC	2019-10-24

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2025-06-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2025-06-01	U	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2024-06-01	U	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2024-06-01	U	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2024-06-01	U	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2024-06-01	U	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2024-06-01	U	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2024-06-01	U	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	014	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	015	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	016	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-10-01	U	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-10-01	U	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-09-01	U	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-09-01	U	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-09-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2023-09-01	U	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2023-09-01	U	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	014	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	015	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	016	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Kamada Ltd.
2022-09-01	U	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-09-01	U	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Kamada Ltd.
2022-01-01	U	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeutics Research Limited
2022-01-01	U	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeutics Research Limited
2022-01-01	U	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeutics Research Limited
2022-01-01	U	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeutics Research Limited
2022-01-01	U	014	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeutics Research Limited
2022-01-01	U	015	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	016	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeutics Research Limited
2022-01-01	U	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2022-01-01	U	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeutics Research Limited
2021-09-01	U	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-09-01	U	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-09-01	U	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-09-01	U	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2021-09-01	U	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2021-09-01	U	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-09-01	U	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2021-09-01	U	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-09-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-05-01	U	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-05-01	U	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-05-01	U	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-05-01	U	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2021-05-01	U	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2021-05-01	U	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-05-01	U	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2021-05-01	U	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2021-05-01	U	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2020-08-01	R	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2020-08-01	R	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2020-08-01	R	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2020-08-01	R	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2020-08-01	R	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2020-08-01	R	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2020-08-01	R	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Saol Therapeuctics Research Limited
2020-08-01	R	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited
2020-08-01	R	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Saol Therapeuctics Research Limited

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2025-06-01	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2025-06-01	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2024-06-01	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2024-06-01	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2024-06-01	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2024-06-01	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2024-06-01	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2015-12-18
2024-06-01	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2015-12-18
2023-10-01	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2023-10-01	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2023-10-01	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2023-10-01	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2023-10-01	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2023-10-01	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2023-10-01	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2023-10-01	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2023-10-01	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2023-10-01	016	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2023-10-01	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2015-12-18
2023-09-01	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2023-09-01	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2023-09-01	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2015-12-18
2023-09-01	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2023-09-01	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2015-12-18
2022-01-01	010	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2022-01-01	011	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2022-01-01	012	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2022-01-01	013	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2022-01-01	014	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2022-01-01	015	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2022-01-01	016	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2022-01-01	017	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2022-01-01	018	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2015-12-18
2020-08-01	001	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2020-08-01	002	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2020-08-01	003	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	1996-04-02
2020-08-01	004	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2020-08-01	005	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2020-08-01	006	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2020-08-01	007	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Rx	Licensed	2005-03-31
2020-08-01	008	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2005-03-31
2020-08-01	009	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	351(a)	Disc	Licensed	2015-12-18

Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized Purple Book BLA 103649

Related Records#

Latest Known Product Presentations#

Published Patent List#

Related NDC Products#

Related DailyMed Labels#

Official Monthly Change Events#

Observed Product State History#