Wellbutrin Xl

Treats major depressive disorder (MDD). NDA 21515, held by Bausch. Bupropion Hydrochloride.

As of Nov 15, 2026, NDA 21515 (Wellbutrin Xl), held by Bausch, was first approved by FDA on Aug 28, 2003, with 27 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2003
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Wellbutrin XL is an aminoketone antidepressant, indicated for:

treatment of major depressive disorder (MDD)
prevention of seasonal affective disorder (SAD) 1.1 Major Depressive Disorder (MDD) Wellbutrin XL (bupropion hydrochloride extended-release) tablets is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Jun 12, 2006	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 28, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Wellbutrin Xl150MG · tablet, extended release;oral	Bupropion Hydrochloride	RxReference drug
Wellbutrin Xl300MG · tablet, extended release;oral	Bupropion Hydrochloride	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


Nov 5, 2025	Supplement 49Labeling · Standard review	Approved	Letter Label Medication Guide
May 7, 2024	Supplement 46Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 44Labeling · Standard review	Approved	Label Letter
Jul 8, 2021	Supplement 43Labeling · Standard review	Approved	Label Letter
Nov 5, 2019	Supplement 40Labeling · Standard review	Approved	Label Letter
May 4, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Aug 30, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
May 24, 2016	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 30, 2014	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 30, 2014	Supplement 29Labeling · Standard review	Approved	Letter Label
Nov 21, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 11, 2014	Supplement 32Labeling	Approved	Label Letter
Aug 2, 2012	Supplement 28REMS	Approved	Letter
Jul 26, 2011	Supplement 27Labeling · Standard review	Approved	Letter Label
Jul 26, 2011	Supplement 26Labeling · Standard review	Approved	Letter Label
May 25, 2010	Supplement 22Labeling · Standard review	Approved	Label Letter
Feb 26, 2010	Supplement 25Labeling · Standard review	Approved	None posted
Jul 1, 2009	Supplement 24Labeling · Standard review	Approved	Label Letter
Jul 1, 2009	Supplement 23Labeling · Standard review	Approved	Label Letter
Aug 2, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 3, 2006	Supplement 14Labeling · Standard review	Approved	Letter Label
Jun 12, 2006	Supplement 18Labeling · Standard review	Approved	Letter Label
Jun 12, 2006	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 28, 2006	Supplement 12Labeling · Standard review	Approved	Letter
Jan 12, 2005	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 28, 2004	Supplement 2Labeling · Standard review	Approved	Letter
May 27, 2004	Supplement 7Labeling · Standard review	Approved	Review Letter
Aug 28, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21515
Drugs@FDA: Overview at FDA
Company: Bausch Health

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