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Active ingredient

Fluvoxamine

44 finished FDA listings contain Fluvoxamine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FLUVOXAMINE MALEATE
Dosage forms
Capsule, Extended Release, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
19
Strengths listed
100 mg/1 · 150 mg/1 · 25 mg/1 · 50 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 42355

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 075902APOTEX2001-05-078
ANDA 075900CHARTWELL RX2006-02-233
NDA 021519ANI PHARMS2007-12-207
ANDA 091476PH HEALTH2013-03-132
ANDA 091482ACTAVIS ELIZABETH2013-04-234
ANDA 212182BIONPHARMA2020-05-112
ANDA 217917BIONPHARMA2024-01-228
ANDA 219055AJANTA PHARMA LTD2024-10-172
ANDA 217024ANNORA PHARMA2025-07-302
ANDA 220328APPCO2026-04-302
ANDA 220447ZYDUS PHARMS2026-07-214

Official labeling on DailyMed

Showing the 12 most recent of 24 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.