Application 103764

Type: BLA
Sponsor: NOVARTIS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103764	Simulect	basiliximab	351(a)	Rx	2026-10-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMULECT	BASILIXIMAB	VIAL; SINGLE-USE	10MG	No	No
002	SIMULECT	BASILIXIMAB	VIAL; SINGLE-USE	20MG	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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43278	ORIG	2004-03-29
39685	SUPPL	2004-03-29
39684	SUPPL	2004-03-29
31629	ORIG	2004-03-29
18623	ORIG	2004-03-29
9429	SUPPL	2004-03-29
9428	SUPPL	2004-03-29
31630	SUPPL	2003-12-04