Application 761067

Type: BLA
Sponsor: SUN PHARMA GLOBAL

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761067	Ilumya	tildrakizumab-asmn	351(a)	Rx	2026-06-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ILUMYA	TILDRAKIZUMAB-ASMN	INJECTABLE;INJECTION	100MG/1ML	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ILUMYA	TILDRAKIZUMAB-ASMN	Sun Pharmaceutical Industries, Inc.	c6a322bb-51b9-4f0e-8642-62a9682ffcde	2026-07-29	Warnings, Adverse reactions	Exact identifier application number: BLA761067 ndc (product): 47335-177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current
47335-177	ILUMYA	tildrakizumab-asmn	Sun Pharmaceutical Industries, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84451	SUPPL	2025-12-18
84417	SUPPL	2025-12-15
78072	SUPPL	2024-04-04
78064	SUPPL	2024-04-04
72981	SUPPL	2022-12-21
72962	SUPPL	2022-12-21
53824	ORIG	2018-04-26
53249	ORIG	2018-03-23
53248	ORIG	2018-03-23
53080	ORIG	2018-03-22