FDA.reportPublic FDA data

Application 022235

Type
NDA
Sponsor
JAZZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUVOXFLUVOXAMINE MALEATETABLET; ORAL25MGYesNo
002LUVOXFLUVOXAMINE MALEATETABLET; ORAL50MGYesNo
003LUVOXFLUVOXAMINE MALEATETABLET; ORAL100MGYesNo

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 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine MaleateFLUVOXAMINE MALEATEPar Health USA, LLCd492230c-f56a-4759-ba86-7090b9f440632026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEAmerican Health Packaging0b107225-ed5a-4461-9184-f3f2bad1892f2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.5198b1c8-8dd6-4b8f-bd85-294ac468af532026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.a4e0212a-ce68-4466-a0e4-f87d5d9ff0b32026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals, Inc.b5b2128d-2363-4966-971f-83219755ecd72026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEBryant Ranch Prepackc3d59ca9-dd42-4b1c-bd2d-23eb507598b82026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack4239fc32-e5cb-4393-b90c-742db42b5d072026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack47daea9e-545d-4a67-b2b2-d12c3c98734b2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.88b5207a-d87b-4541-ac6b-aa1c51715fcf2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEAvKARE4527a684-51c0-1858-e063-6394a90a26312025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEAjanta Pharma USA Inc.0a6836ab-bd0e-410b-82af-07720e3865322025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutions35b377d9-5b7a-4d8e-b6c1-4291d02f5dae2025-10-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEPD-Rx Pharmaceuticals, Inc.9972efbb-46cd-45b7-b71c-35032311b70c2025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEApotex Corp6eeb14df-6fcf-a737-5359-5744eb4accea2025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.642b7b5e-9f1c-479b-b9b3-bf06774f7b602025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATECamber Pharmaceuticals, Inc.e5574f41-d4df-42d5-baae-b317fb7c88bf2025-08-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEANI Pharmaceuticals, Inc.7ecd83ec-88f5-4f85-9cc2-9068375d88202025-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutionsddc9e7e8-f041-43bb-970b-cd4b303676372025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEActavis Pharma, Inc.8bbd7e39-b9ab-4716-9522-aa8c4b92210e2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.191912e6-b3c8-be1a-e063-6394a90a8dd42025-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUVOXAMINE MALEATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44176ORIG2012-02-13
43839ORIG2011-04-01
44710ORIG2009-09-03
21965ORIG2009-09-03
7076ORIG2008-05-22
17109ORIG2008-04-23