Ipol Purple Book BLA 103930

BLA number: 103930
Proprietary names: Ipol
Proper names: Poliovirus Vaccine Inactivated
Applicant: Sanofi Winthrop Industrie
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	Patent list provided
001	Ipol	Poliovirus Vaccine Inactivated	351(a)	32/40/8 DAU/.5ML	Injection	Intramuscular	Multi-Dose Vial	Rx	Licensed	2000-02-04
002	Ipol	Poliovirus Vaccine Inactivated	351(a)	32/40/8 DAU/.5ML	Injection	Subcutaneous	Multi-Dose Vial	Rx	Licensed	2000-02-04

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
49281-860	IPOL	POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), and POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	current
50090-1693	IPOL	POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), and POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)	A-S Medication Solutions	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Poliovirus Vaccine Inactivated IPOL ®	Sanofi Vaccines US Inc. \| Sanofi Winthrop Industrie	2026-06-10
Poliovirus Vaccine Inactivated IPOL ®	Sanofi Vaccines US Inc. \| Sanofi Winthrop Industrie	2026-06-03
Poliovirus Vaccine Inactivated IPOL ®	Sanofi Pasteur Inc. \| Sanofi Winthrop Industrie	2026-01-30
IPOL	A-S Medication Solutions	2024-11-04

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-03-01	U	001	Ipol	351(a)	Rx	Sanofi Winthrop Industrie
2026-03-01	U	002	Ipol	351(a)	Rx	Sanofi Winthrop Industrie
2026-02-01	U	001	Ipol	351(a)	Rx	Sanofi Pasteur Winthrop Industrie
2026-02-01	U	002	Ipol	351(a)	Rx	Sanofi Pasteur Winthrop Industrie
2022-01-01	U	001	Ipol	351(a)	Rx	Sanofi Pasteur SA
2022-01-01	U	002	Ipol	351(a)	Rx	Sanofi Pasteur SA
2021-05-01	U	001	Ipol	351(a)	Rx	Sanofi Pasteur SA
2020-08-01	R	001	Ipol	351(a)	Rx	Sanofi Pasteur SA

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2022-01-01	002	Ipol	351(a)	Rx	Licensed	2000-02-04
2020-08-01	001	Ipol	351(a)	Rx	Licensed	2000-02-04