Pexeva

NDA 21299, held by Sebela Ireland Ltd. Paroxetine Mesylate.

As of Nov 15, 2026, NDA 21299 (Pexeva), held by Sebela Ireland Ltd, was first approved by FDA on Jul 3, 2003, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 3, 2003
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Dec 9, 2006	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 9, 2006	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 9, 2006	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 3, 2003	Original applicationNew active ingredient · Standard review	Approved	Letter Letter Label Label

Products

4 strengths and forms


PexevaEQ 10MG BASE · tablet;oral	Paroxetine Mesylate	DiscontinuedReference drug
PexevaEQ 20MG BASE · tablet;oral	Paroxetine Mesylate	DiscontinuedReference drug
PexevaEQ 30MG BASE · tablet;oral	Paroxetine Mesylate	DiscontinuedReference drug
PexevaEQ 40MG BASE · tablet;oral	Paroxetine Mesylate	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 38Labeling · Standard review	Approved	Medication Guide Label Letter
Aug 18, 2023	Supplement 35Labeling · Standard review	Approved	Label Letter
Sep 20, 2021	Supplement 37Labeling	Approved	Letter Label
Dec 31, 2020	Supplement 31Labeling · Standard review	Approved	Label Letter
Jan 4, 2017	Supplement 33Labeling	Approved	Letter Label
Jul 18, 2014	Supplement 32Labeling	Approved	Letter Label
Dec 18, 2012	Supplement 29Labeling · Standard review	Approved	Letter
Dec 18, 2012	Supplement 28Labeling · Standard review	Approved	Letter
Dec 18, 2012	Supplement 27Labeling · Standard review	Approved	Letter
Nov 26, 2012	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 28, 2011	Supplement 24Labeling · Standard review	Approved	Letter Label
Jan 29, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 30, 2009	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 6, 2008	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 5, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 3, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 9, 2006	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 9, 2006	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 9, 2006	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 13Labeling · Standard review	Approved	Letter Label
Aug 30, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Aug 21, 2003	Supplement 1Labeling · Standard review	Approved	Review Letter
Jul 3, 2003	Original applicationNew active ingredient · Standard review	Approved	Letter Letter Label Label

Identifiers

Application: NDA 21299
Drugs@FDA: Overview at FDA
Company: Sebela Ireland

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