Ontruzant Purple Book BLA 761100

BLA number: 761100
Proprietary names: Ontruzant
Proper names: trastuzumab-dttb
Applicant: Samsung Bioepis Co., Ltd.
Center: CDER
First observed release: 2020-02-01
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	Ontruzant	trastuzumab-dttb	351(k) Biosimilar	150MG	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2019-01-18
002	Ontruzant	trastuzumab-dttb	351(k) Biosimilar	420MG	For Injection	Intravenous	Multi-Dose Vial	Rx	Licensed	2020-03-20
005	Ontruzant	trastuzumab-dttb	351(k) Biosimilar	420MG	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2020-03-20

Reference Biological Product#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103792	Herceptin	trastuzumab	351(a)	Disc*	2026-06-01

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
78206-147	Ontruzant	trastuzumab	Organon LLC	current
78206-148	Ontruzant	Ontruzant	Organon LLC	current
0006-5033	Ontruzant	trastuzumab	Merck Sharp & Dohme Corp.	legacy
0006-5034	Ontruzant	Ontruzant	Merck Sharp & Dohme Corp.	legacy

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Ontruzant	Organon LLC \| Samsung Bioepis Co., Ltd.	2026-04-20
Ontruzant	Merck Sharp & Dohme Corp. \| Samsung Bioepis Co., Ltd.	2020-04-02

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2022-03-01	U	002	Ontruzant	351(k) Biosimilar	Rx	Samsung Bioepis Co., Ltd.
2021-06-01	U	002	Ontruzant	351(k) Biosimilar	Rx	Samsung Bioepis Co., Ltd.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2021-06-01	002	Ontruzant	351(k) Biosimilar	Rx	Licensed	2020-03-20
2020-05-01	001	Ontruzant	351(k) Biosimilar	Rx	Licensed	2019-01-18
2020-05-01	005	Ontruzant	351(k) Biosimilar	Rx	Licensed	2020-03-20
2020-02-01	001	Ontruzant	351(k) Biosimilar	Marketed	Licensed	2019-01-18