Application 761025

Type: BLA
Sponsor: BOEHRINGER INGELHEIM

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761025	Praxbind	idarucizumab	351(a)	Rx	2026-06-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAXBIND	IDARUCIZUMAB	INJECTABLE;INJECTION	2.5G/50ML	No	No

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Praxbind	IDARUCIZUMAB	Boehringer Ingelheim Pharmaceuticals, Inc.	c7400f8a-dcf4-a6df-6d07-983081b1bf34	2024-01-23	Warnings, Adverse reactions	Exact identifier application number: BLA761025 ndc (product): 0597-0197

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0197	Praxbind	idarucizumab	Boehringer Ingelheim Pharmaceuticals, Inc.	BLA	Current
0597-0197	Praxbind	idarucizumab	Boehringer Ingelheim Pharmaceuticals, Inc.	BLA	Current
0597-0197	Praxbind	idarucizumab	Boehringer Ingelheim Pharmaceuticals, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70168	SUPPL	2022-02-15
70161	SUPPL	2022-02-14
53689	SUPPL	2018-04-16
53660	SUPPL	2018-04-12
43551	ORIG	2015-11-13
10660	ORIG	2015-10-20
40638	ORIG	2015-10-16