Wellbutrin

NDA 18644, held by Glaxosmithkline. Bupropion Hydrochloride.

As of Nov 14, 2026, NDA 18644 (Wellbutrin), held by Glaxosmithkline, was first approved by FDA on Dec 30, 1985, with 53 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1985
Review: Priority
Supplements approved: 53
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 54 submissions below

Date	Submission	Status	Documents
Dec 30, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Products

3 strengths and forms


Wellbutrin50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bupropion Hydrochloride	DiscontinuedReference drug
Wellbutrin75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bupropion Hydrochloride	DiscontinuedReference drug
Wellbutrin100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bupropion Hydrochloride	DiscontinuedReference drug

All 54 submissions, including labeling and manufacturing supplements


Nov 5, 2025	Supplement 64Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 5, 2025	Supplement 62Labeling · Standard review	Approved	Label Letter
May 7, 2024	Supplement 61Labeling · Standard review	Approved	Label Letter
Dec 6, 2022	Supplement 59Labeling · Standard review	Approved	Label Letter
Oct 20, 2020	Supplement 57Labeling · Standard review	Approved	Label Letter
Nov 5, 2019	Supplement 54Labeling · Standard review	Approved	Label Letter
Aug 11, 2017	Supplement 53Labeling · Standard review	Approved	Letter Label
May 10, 2017	Supplement 51Labeling · Standard review	Approved	Letter Label
May 4, 2017	Supplement 52Labeling · Standard review	Approved	Letter Label
Apr 25, 2016	Supplement 50Labeling · Standard review	Approved	Letter Label
Dec 16, 2014	Supplement 48Labeling · Standard review	Approved	Letter Label
Jul 17, 2014	Supplement 49Labeling	Approved	Label Letter
Dec 23, 2013	Supplement 46Labeling · Standard review	Approved	Review Letter Label
Dec 23, 2013	Supplement 47Labeling · Standard review	Approved	Review Letter Label
Mar 19, 2013	Supplement 45Labeling · Standard review	Approved	Label Letter
Aug 2, 2012	Supplement 44REMS	Approved	Letter
Jul 25, 2011	Supplement 43Labeling · Standard review	Approved	Letter Label
May 17, 2011	Supplement 42Labeling · Standard review	Approved	Label Letter
May 25, 2010	Supplement 38Labeling · Standard review	Approved	Label Letter
Feb 26, 2010	Supplement 41Labeling · Standard review	Approved	Letter
Jul 1, 2009	Supplement 39Labeling · Standard review	Approved	Letter Label
Jul 1, 2009	Supplement 40Labeling · Standard review	Approved	Letter Label
Aug 2, 2007	Supplement 36Labeling · Standard review	Approved	Letter Label
Jan 29, 2007	Supplement 35Labeling · Standard review	Approved	Letter
Jul 3, 2006	Supplement 33Labeling · Standard review	Approved	Letter Label
Jul 3, 2006	Supplement 34Labeling · Standard review	Approved	Review Letter Label
Feb 28, 2006	Supplement 31Labeling · Standard review	Approved	Letter
Jan 12, 2005	Supplement 30Labeling · Standard review	Approved	Letter Label
May 27, 2004	Supplement 28Labeling · Standard review	Approved	Review Letter
Oct 22, 2002	Supplement 26Labeling · Standard review	Approved	Letter
Oct 2, 2002	Supplement 24Labeling · Standard review	Approved	Letter
Jun 20, 2002	Supplement 22Labeling · Standard review	Approved	Letter
Jun 20, 2002	Supplement 23Labeling · Standard review	Approved	Letter
Feb 13, 2002	Supplement 25Manufacturing · Priority review	Approved	Letter
Apr 10, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 15Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 17Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 18Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 19Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 20Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 21Labeling · Standard review	Approved	None posted
Oct 31, 1996	Supplement 13Manufacturing · Priority review	Approved	Review
Nov 27, 1995	Supplement 10Labeling · Standard review	Approved	Review
Nov 27, 1995	Supplement 12Labeling · Standard review	Approved	Review
Mar 23, 1994	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 23, 1994	Supplement 6Manufacturing · Priority review	Approved	None posted
Mar 23, 1994	Supplement 7Manufacturing · Priority review	Approved	None posted
Jun 24, 1991	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 24, 1991	Supplement 8Labeling	Approved	None posted
May 30, 1989	Supplement 3Manufacturing · Priority review	Approved	None posted
Feb 11, 1986	Supplement 1Labeling	Approved	None posted
Feb 11, 1986	Supplement 2Labeling	Approved	None posted
Dec 30, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Show all 54

Identifiers

Application: NDA 18644
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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