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PAXIL

paroxetine hydrochloride · Tablet, Film Coated, Extended Release

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PAXIL CR
Generic name
paroxetine hydrochloride
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Apotex Corp
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Paroxetine Hydrochloride 12.5 mg/1 1738495 View
Paroxetine Hydrochloride 25 mg/1 1738495 View
Paroxetine Hydrochloride 37.5 mg/1 1738495 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Serotonin Reuptake Inhibitor [EPC] EPC All 51 members
Serotonin Uptake Inhibitors [MoA] MoA All 73 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020936
Application type
NDA · New Drug Application
Approval date
February 16, 1999
Sponsor
APOTEX
Products on application
3
Submissions recorded
42
Products approved under application 020936.
Product Trade name Form Strength Ingredient Status TE Flags
020936-001 PAXIL CR TABLET, EXTENDED RELEASE PAROXETINE HYDROCHLORIDE Prescription AB RLD
020936-002 PAXIL CR TABLET, EXTENDED RELEASE PAROXETINE HYDROCHLORIDE Prescription AB RLD
020936-003 PAXIL CR TABLET, EXTENDED RELEASE PAROXETINE HYDROCHLORIDE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020936.
Type No. Action Status Date Review
Supplement 65 Labeling Approved February 23, 2024 Standard
Supplement 64 Labeling Approved August 18, 2023 Standard
Supplement 57 Labeling Approved August 18, 2023 Standard
Supplement 60 Labeling Approved September 20, 2021 901 Required
Supplement 47 Labeling Approved September 11, 2019 Standard
Supplement 53 Labeling Approved January 4, 2017 901 Required
Supplement 49 Labeling Approved July 18, 2014 901 Required
Supplement 45 Labeling Approved December 18, 2012 Standard
Supplement 46 Labeling Approved April 10, 2012 Standard
Supplement 44 Labeling Approved July 8, 2011 Standard
Supplement 34 Labeling Approved July 8, 2011 Standard
Supplement 43 Labeling Approved March 21, 2011 Unknown
Supplement 40 Labeling Approved March 21, 2011 Standard
Supplement 41 Labeling Approved October 27, 2010 Standard
Supplement 35 Labeling Approved August 7, 2009 Standard
Supplement 39 Manufacturing (CMC) Approved July 17, 2009 Standard
Supplement 38 Labeling Approved January 30, 2009 Standard
Supplement 37 Labeling Approved October 31, 2008 Standard
Supplement 29 Labeling Approved August 2, 2007 Standard
Supplement 31 Labeling Approved August 22, 2006 Standard
Supplement 30 Labeling Approved August 22, 2006 Standard
Supplement 23 Labeling Approved August 22, 2006 Standard
Supplement 21 Labeling Approved March 9, 2006 Standard
Supplement 27 Labeling Approved February 6, 2006 Standard
Supplement 26 Labeling Approved February 6, 2006 Standard
Supplement 22 Labeling Approved February 6, 2006 Standard
Supplement 18 Labeling Approved July 13, 2005 Standard
Supplement 20 Labeling Approved January 12, 2005 Standard
Supplement 19 Labeling Approved May 21, 2004 Standard
Supplement 13 Efficacy Approved January 27, 2004 Standard
Supplement 12 Efficacy Approved October 16, 2003 Standard
Supplement 11 Efficacy Approved August 28, 2003 Standard
Supplement 9 Manufacturing (CMC) Approved July 22, 2002 Standard
Supplement 8 Labeling Approved February 12, 2002 Standard
Supplement 7 Manufacturing (CMC) Approved April 30, 2001 Standard
Supplement 6 Manufacturing (CMC) Approved April 30, 2001 Standard
Supplement 5 Manufacturing (CMC) Approved December 6, 2000 Standard
Supplement 3 Manufacturing (CMC) Approved September 21, 2000 Standard
Supplement 2 Manufacturing (CMC) Approved August 17, 2000 Standard
Supplement 4 Manufacturing (CMC) Approved July 18, 2000 Standard
Supplement 1 Manufacturing (CMC) Approved July 2, 1999 Standard
Original application 1 Type 3 - New Dosage Form Approved February 16, 1999 Standard

Review documents

  • 0 · Supplement · February 27, 2024
  • 0 · Supplement · February 26, 2024
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · October 1, 2021
  • 0 · Supplement · September 23, 2021
  • 0 · Supplement · September 12, 2019
  • 0 · Supplement · September 12, 2019
  • 0 · Supplement · January 13, 2017
  • 0 · Supplement · January 6, 2017
  • 0 · Supplement · July 30, 2014
  • 0 · Supplement · July 23, 2014
  • 0 · Supplement · December 31, 2012
  • 0 · Supplement · December 21, 2012
  • 0 · Supplement · April 17, 2012
  • 0 · Supplement · April 12, 2012
  • 0 · Supplement · December 9, 2011
  • 0 · Supplement · December 9, 2011
  • 0 · Supplement · December 9, 2011
  • 0 · Supplement · December 9, 2011
  • 0 · Supplement · December 9, 2011
  • 0 · Supplement · December 9, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · July 12, 2011
  • 0 · Supplement · March 28, 2011

Adverse event reports

Source: openFDA FAERS
41,104
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PAROXETINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
60505-4377-3 60505-4377 Apotex Corp 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4377-3) January 1, 2011
60505-4378-3 60505-4378 Apotex Corp 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4378-3) January 1, 2011
60505-4379-3 60505-4379 Apotex Corp 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4379-3) January 1, 2011
60505-4377 60505-4377 Apotex Corp — January 1, 2011
60505-4378 60505-4378 Apotex Corp — January 1, 2011
60505-4379 60505-4379 Apotex Corp — January 1, 2011

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.