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FDA NDA · NDA018644

WELLBUTRIN

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APPLICATION
NDA018644
TYPE
NDA
ORIGINAL APPROVAL
1985-12-30
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

WELLBUTRIN · ReferenceDiscontinued
BUPROPION HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
WELLBUTRIN · ReferenceDiscontinued
BUPROPION HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
WELLBUTRIN · ReferenceDiscontinued
BUPROPION HYDROCHLORIDE 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-11-05Labeling · Supplement 64 · standardLetterAP
2025-02-05Labeling · Supplement 62 · standardLetterAP
2024-05-07Labeling · Supplement 61 · standardLetterAP
2022-12-06Labeling · Supplement 59 · standardLetterAP
2020-10-20Labeling · Supplement 57 · standardLetterAP
2019-11-05Labeling · Supplement 54 · standardLetterAP
2017-08-11Labeling · Supplement 53 · standardLabelAP
2017-05-10Labeling · Supplement 51 · standardLabelAP
2017-05-04Labeling · Supplement 52 · standardLabelAP
2016-04-25Labeling · Supplement 50 · standardLetterAP
2014-12-16Labeling · Supplement 48 · standardLetterAP
2014-07-17Labeling · Supplement 49 · 901 requiredLetterAP
2013-12-23Labeling · Supplement 47 · standardLetterAP
2013-12-23Labeling · Supplement 46 · standardLabelAP
2013-03-19Labeling · Supplement 45 · standardLetterAP
2012-08-02REMS · Supplement 44LetterAP
2011-07-25Labeling · Supplement 43 · standardLabelAP
2011-05-17Labeling · Supplement 42 · standardLetterAP
2010-05-25Labeling · Supplement 38 · standardLabelAP
2010-02-26Labeling · Supplement 41 · standardLetterAP
2009-07-01Labeling · Supplement 39 · standardLetterAP
2009-07-01Labeling · Supplement 40 · standardLetterAP
2007-08-02Labeling · Supplement 36 · standardLetterAP
2007-01-29Labeling · Supplement 35 · standardLetterAP
2006-07-03Labeling · Supplement 33 · standardLabelAP
2006-07-03Labeling · Supplement 34 · standardReviewAP
2006-02-28Labeling · Supplement 31 · standardLetterAP
2005-01-12Labeling · Supplement 30 · standardLetterAP
2004-05-27Labeling · Supplement 28 · standardReviewAP
2002-10-22Labeling · Supplement 26 · standardLetterAP
2002-10-02Labeling · Supplement 24 · standardLetterAP
2002-06-20Labeling · Supplement 22 · standardLetterAP
2002-06-20Labeling · Supplement 23 · standardLetterAP
2002-02-13Manufacturing (CMC) · Supplement 25 · priorityLetterAP
2000-04-10Labeling · Supplement 16 · standardAP
2000-04-10Labeling · Supplement 14 · standardAP
2000-04-10Labeling · Supplement 20 · standardAP
2000-04-10Labeling · Supplement 19 · standardAP
2000-04-10Labeling · Supplement 17 · standardAP
2000-04-10Labeling · Supplement 15 · standardAP
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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