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	2026-10-01

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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