← FDA DRUG APPROVALS

FDA NDA · NDA020358

WELLBUTRIN SR

bupropion hydrochloride

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020358
TYPE
NDA
ORIGINAL APPROVAL
1996-10-04
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued

Products

WELLBUTRIN SR · ReferencePrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
WELLBUTRIN SRDiscontinued
BUPROPION HYDROCHLORIDE 50MG · TABLET, EXTENDED RELEASE · ORAL
WELLBUTRIN SR · ReferencePrescription
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
WELLBUTRIN SR · ReferencePrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-11-05Labeling · Supplement 70 · standard — Letter ↗AP
2024-05-07Labeling · Supplement 68 · standard — Letter ↗AP
2022-12-06Labeling · Supplement 66 · standard — Letter ↗AP
2020-10-20Labeling · Supplement 64 · standard — Letter ↗AP
2019-11-05Labeling · Supplement 61 · standard — Letter ↗AP
2017-08-11Labeling · Supplement 60 · standard — Label ↗AP
2017-05-10Labeling · Supplement 58 · standard — Label ↗AP
2017-05-04Labeling · Supplement 59 · standard — Label ↗AP
2016-04-25Labeling · Supplement 57 · standard — Letter ↗AP
2014-12-16Labeling · Supplement 55 · standard — Label ↗AP
2014-07-17Labeling · Supplement 56 · 901 required — Label ↗AP
2013-12-23Labeling · Supplement 54 · standard — Letter ↗AP
2013-12-23Labeling · Supplement 53 · standard — Review ↗AP
2013-03-19Labeling · Supplement 52 · standard — Letter ↗AP
2012-08-02REMS · Supplement 51 — Letter ↗AP
2011-07-25Labeling · Supplement 50 · standard — Letter ↗AP
2011-05-17Labeling · Supplement 49 · standard — Letter ↗AP
2011-05-17Labeling · Supplement 39 · standard — Letter ↗AP
2010-05-25Labeling · Supplement 45 · standard — Letter ↗AP
2010-02-26Labeling · Supplement 48 · standard — Letter ↗AP
2009-07-01Labeling · Supplement 46 · standard — Label ↗AP
2009-07-01Labeling · Supplement 47 · standard — Label ↗AP
2007-08-02Labeling · Supplement 43 · standard — Label ↗AP
2007-01-29Labeling · Supplement 42 · standard — Letter ↗AP
2006-07-03Labeling · Supplement 40 · standard — Review ↗AP
2006-07-03Labeling · Supplement 37 · standard — Letter ↗AP
2006-02-28Labeling · Supplement 35 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 34 · standard — Label ↗AP
2004-05-27Labeling · Supplement 32 · standard — Review ↗AP
2004-04-26Labeling · Supplement 30 · standard — Letter ↗AP
2002-10-22Labeling · Supplement 29 · standard — Letter ↗AP
2002-10-02Labeling · Supplement 24 · standard — Letter ↗AP
2002-07-12Manufacturing (CMC) · Supplement 28 · standard — Letter ↗AP
2002-07-12Manufacturing (CMC) · Supplement 26 · standardAP
2002-06-20Labeling · Supplement 23 · standard — Letter ↗AP
2002-06-20Labeling · Supplement 18 · standard — Letter ↗AP
2002-06-14Manufacturing (CMC) · Supplement 27 · standard — Label ↗AP
2002-02-13Manufacturing (CMC) · Supplement 25 · standard — Review ↗AP
2001-06-11Efficacy · Supplement 19 · standard — Review ↗AP
2000-10-11Manufacturing (CMC) · Supplement 21 · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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