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Active ingredient

Paroxetine

168 finished FDA listings contain Paroxetine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE ANHYDROUS, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE MESYLATE
Dosage forms
Capsule, Suspension, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
48
Strengths listed
10 mg/1 · 10 mg/5ml · 12.5 mg/1 · 20 mg/1 · 25 mg/1 · 30 mg/1 · 37.5 mg/1 · 40 mg/1 · 7.5 mg/1
Brand names in FDA listings
Brisdelle, Paroxetine, Paxil, Paxil Cr

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 32937

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
NDA 020031APOTEX1992-12-294
NDA 020936APOTEX1999-02-166
ANDA 075356APOTEX2003-07-3017
ANDA 077584ZYDUS PHARMS USA2007-03-0742
ANDA 078406AUROBINDO PHARMA2007-07-2520
ANDA 078902MYLAN2008-03-1311
ANDA 076968OXFORD PHARMS2010-06-215
NDA 204516LEGACY2013-06-282
ANDA 203854PRINSTON INC2014-10-3125
ANDA 204744LANNETT CO INC2016-06-107
ANDA 204134LUPIN2017-01-203
ANDA 207188PRINSTON INC2017-08-181
ANDA 213485CSPC OUYI2021-02-163
ANDA 212645CADILA PHARMS LTD2021-08-276
ANDA 215003NOVITIUM PHARMA2021-09-031
ANDA 211248YILING2021-11-028
ANDA 217280ALEMBIC2025-09-246
ANDA 219954ANNORA PHARMA2026-03-051

Official labeling on DailyMed

Showing the 12 most recent of 84 labels.

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