Application 218276

Type: NDA
Sponsor: NOVARTIS

Related Records

Company: NOVARTIS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FABHALTA	IPTACOPAN HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG BASE	Yes	Yes

Documents

Document	Submission type	Date
81681	SUPPL	2025-03-24
81662	SUPPL	2025-03-20
81661	SUPPL	2025-03-20
79352	SUPPL	2024-08-09
79326	SUPPL	2024-08-07
78565	SUPPL	2024-05-28
77999	SUPPL	2024-03-27
77981	SUPPL	2024-03-27
77151	ORIG	2023-12-27
76744	ORIG	2023-12-06
76739	ORIG	2023-12-06