FDA.reportPublic FDA data

Application 018644

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELLBUTRINBUPROPION HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002WELLBUTRINBUPROPION HYDROCHLORIDETABLET;ORAL75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003WELLBUTRINBUPROPION HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018644-001WELLBUTRINBUPROPION HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30
N018644-002WELLBUTRINBUPROPION HYDROCHLORIDE75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30
N018644-003WELLBUTRINBUPROPION HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3084e616aacf4f…
2026-08-18 06:07:402026-07N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018644-002WELLBUTRIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018644-003WELLBUTRIN100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018644-001WELLBUTRIN50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1985-12-30301d65b070ca…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAsclemed USA, Inc.d1d0872c-5b11-4e13-a401-b122348e0fa72026-03-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochlorideBUPROPION HYDROCHLORIDERising Pharma Holdings, Inc.e4f4d3fa-ddf6-4125-8486-8157efc095c12026-03-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutionsd86e26e0-6e10-4d59-8cc8-94b551774b862026-03-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsb127d3fc-be5e-4c12-8026-205766bf8e7f2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEEpic Pharma, LLCf79d1422-a9b6-41c2-a46d-22886605f94d2026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEEpic Pharma, LLCf56ccdb1-f9d9-3e5f-e053-2995a90a8f162026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4bd469b8-fb35-0223-e063-6294a90ae7bc2026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3bcdf7-d7f3-4f07-8113-af08af20a0d42026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAvPAKbcb4ef83-f272-4090-8547-9aaf4ab636672026-02-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9d0608a1-0cc8-491a-ad91-238e0ea009fe2026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEDr. Reddys Laboratories Inc.ad784c8e-7201-4336-a310-616e3e979ca42026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
WELLBUTRIN XLBUPROPION HYDROCHLORIDEBausch Health US LLCa435da9d-f6e8-4ddc-897d-8cd2bf777b212026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions039d4368-c764-463a-b0cd-1cac702b8fb22026-02-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions6902b252-dc69-4b3c-bad2-b6667a5f6d842026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDERADHA PHARMACEUTICALS, INC.16a788ff-8bd5-4f70-a3fd-a89db019e4352026-02-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEScieGen Pharmaceuticals,Inc.05f82eca-cc87-4580-acd7-e6491c6518812026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEMullan Pharmaceutical Inc.75b1e027-4c5d-46e5-98ee-033e67bd411c2026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBluePoint Laboratories4956af38-182a-4015-a945-67e40bd387722026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.093c4a61-02d9-4b55-b612-569aa25d3f2a2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEScieGen Pharmaceuticals, Inc.092da413-ec60-4577-ac57-51e3e42d55c92026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84107SUPPL 2025-11-06
84106SUPPL 2025-11-06
84078SUPPL 2025-11-06
82435SUPPL 2025-06-03
81111SUPPL 2025-02-06
78429SUPPL 2024-05-08
78418SUPPL 2024-05-07
72827SUPPL2022-12-08
72826SUPPL2022-12-08
72818SUPPL2022-12-07
65004SUPPL2020-10-23
65003SUPPL2020-10-23
64971SUPPL2020-10-22
60829SUPPL2019-11-13
60828SUPPL2019-11-13
60800SUPPL2019-11-08
49479SUPPL2017-08-21
49456SUPPL2017-08-18
48359SUPPL2017-05-12
48354SUPPL2017-05-10
48303SUPPL2017-05-09
48263SUPPL2017-05-08
33536SUPPL2016-04-27
15066SUPPL2016-04-27
33534SUPPL2014-12-17
988SUPPL2014-12-17
33535SUPPL2014-07-22
15065SUPPL2014-07-21
20140SUPPL2014-07-07
20139SUPPL2014-07-07
15064SUPPL2013-12-26
987SUPPL2013-12-26
33533SUPPL2013-12-24
11257SUPPL2013-12-24
33532SUPPL2013-03-26
986SUPPL2013-03-21
15063SUPPL2012-08-03
40814SUPPL2012-06-26
15062SUPPL2011-07-28
11256SUPPL2011-07-25
33531SUPPL2011-05-23
15061SUPPL2011-05-19
11254SUPPL2010-05-28
15058SUPPL2010-05-27
15060SUPPL2010-03-03
15059SUPPL2009-07-07
985SUPPL2009-07-07
33530SUPPL2009-07-06
11255SUPPL2009-07-06
15057SUPPL2007-08-07
33529SUPPL2007-08-03
40813SUPPL2007-06-29
984SUPPL2007-02-02
983SUPPL2006-07-13
982SUPPL2006-07-13
33528SUPPL2006-07-05
11253SUPPL2006-07-05
15056SUPPL2006-03-03
44024ORIG2005-07-28
11252SUPPL2005-01-13
981SUPPL2005-01-13
980SUPPL2004-06-01
40812SUPPL2003-06-17
40811SUPPL2003-06-17
20138SUPPL2003-06-17
15055SUPPL2002-10-22
15053SUPPL2002-10-02
979SUPPL2002-10-02
15052SUPPL2002-06-20
15054SUPPL2002-02-12
57442ORIG1985-12-30