Paxil

NDA 20710, held by Apotex. Paroxetine Hydrochloride.

As of Nov 13, 2026, NDA 20710 (Paxil), held by Apotex, was first approved by FDA on Jun 25, 1997, with 34 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1997
Review: Standard
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Jun 25, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PaxilEQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suspension;oral	Paroxetine Hydrochloride	DiscontinuedReference drug

All 35 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 49Labeling · Standard review	Approved	Label Letter
Nov 26, 2024	Supplement 51Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 18, 2023	Supplement 50Labeling · Standard review	Approved	None posted
Sep 20, 2021	Supplement 47Labeling	Approved	Label Letter
Feb 6, 2021	Supplement 45Labeling · Standard review	Approved	Label Letter
Jan 4, 2017	Supplement 38Labeling	Approved	Letter Label
Jul 18, 2014	Supplement 35Labeling	Approved	Label Letter
Dec 18, 2012	Supplement 31Labeling · Standard review	Approved	Label Letter
Apr 10, 2012	Supplement 32Labeling · Standard review	Approved	Label Letter
Jul 8, 2011	Supplement 22Labeling · Standard review	Approved	Letter Label
Jul 8, 2011	Supplement 30Labeling · Standard review	Approved	Letter Label
Mar 21, 2011	Supplement 26Labeling · Standard review	Approved	Label Letter
Mar 21, 2011	Supplement 29Labeling	Approved	Label Letter
Mar 21, 2011	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 27, 2010	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 7, 2009	Supplement 23Labeling · Standard review	Approved	Letter Label
Jan 30, 2009	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 31, 2008	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 2, 2007	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 22, 2006	Supplement 18Labeling · Standard review	Approved	Letter
Aug 22, 2006	Supplement 19Labeling · Standard review	Approved	Letter
Feb 6, 2006	Supplement 15Labeling · Standard review	Approved	Letter
Feb 6, 2006	Supplement 16Labeling · Standard review	Approved	Letter
Nov 8, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 30, 2001	Supplement 11Manufacturing · Standard review	Approved	Review
Apr 30, 2001	Supplement 10Manufacturing · Standard review	Approved	Review
Feb 15, 2001	Supplement 9Labeling · Standard review	Approved	None posted
Sep 28, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Sep 21, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 18, 2000	Supplement 7Manufacturing · Standard review	Approved	Review
Jun 27, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 23, 1999	Supplement 4Manufacturing · Standard review	Approved	Review
Feb 20, 1998	Supplement 2Manufacturing · Standard review	Approved	Review
Nov 6, 1997	Supplement 1Manufacturing · Standard review	Approved	Review
Jun 25, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20710
Drugs@FDA: Overview at FDA
Company: Apotex

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters