Application 022235

Type: NDA
Sponsor: JAZZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUVOX	FLUVOXAMINE MALEATE	TABLET; ORAL	25MG	Yes	No
002	LUVOX	FLUVOXAMINE MALEATE	TABLET; ORAL	50MG	Yes	No
003	LUVOX	FLUVOXAMINE MALEATE	TABLET; ORAL	100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Chartwell RX, LLC	b8320308-084f-43fb-9b1d-5620a0efaf46	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	9924422b-7c90-42bf-a680-ffd92063d5f0	2024-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44176	ORIG	2012-02-13
43839	ORIG	2011-04-01
44710	ORIG	2009-09-03
21965	ORIG	2009-09-03
7076	ORIG	2008-05-22
17109	ORIG	2008-04-23