Application 018644

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WELLBUTRIN	BUPROPION HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	WELLBUTRIN	BUPROPION HYDROCHLORIDE	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	WELLBUTRIN	BUPROPION HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018644-001	WELLBUTRIN	BUPROPION HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30
N018644-002	WELLBUTRIN	BUPROPION HYDROCHLORIDE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30
N018644-003	WELLBUTRIN	BUPROPION HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018644-002	WELLBUTRIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018644-003	WELLBUTRIN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`301d65b070ca…`

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 1 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Apotex Corp	86530199-999b-9f92-b1bc-b8515ec829f3	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	136f29fa-a859-4efb-8365-1382716d6f8f	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	81d251aa-a8e8-493e-94ed-12f6fb8902e6	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d9eb0939-63c1-48c4-a444-a899d7924d06	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0b041720-a25d-403e-a72c-601a8bdd8051	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	b47c5515-a438-40bc-b8ad-26a6cf9676b7	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	6087100f-3ba4-412e-b08d-768d1dcdaf00	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0aa86bd6-b37b-45f7-a837-b067e41184e9	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	bcbef1b4-a135-4231-bc65-7d0b335260e8	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	56df4e22-81ca-48a4-a8e2-038448417355	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5f8b3313-0286-499f-9235-02cdc0eb063b	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	334e5635-e4cc-cf2a-e063-6294a90ae1e1	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c4	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	439a7e93-f578-434f-943f-4b93c35450f5	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5829a2aa-4845-b58b-e063-6294a90ad2f4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	30c370c2-f2b7-4335-ba55-e8c8f4059092	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	080853c0-fcab-4645-9ddc-4946e895ac5f	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	aa3d3e5b-74a3-47f6-b9aa-d6e248e950e5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	cc344f7c-0eb3-4e63-a09e-b682acca2bb5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name 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
Document	Submission type	Date
84107	SUPPL	2025-11-06
84106	SUPPL	2025-11-06
84078	SUPPL	2025-11-06
82435	SUPPL	2025-06-03
81111	SUPPL	2025-02-06
78429	SUPPL	2024-05-08
78418	SUPPL	2024-05-07
72827	SUPPL	2022-12-08
72826	SUPPL	2022-12-08
72818	SUPPL	2022-12-07
65004	SUPPL	2020-10-23
65003	SUPPL	2020-10-23
64971	SUPPL	2020-10-22
60829	SUPPL	2019-11-13
60828	SUPPL	2019-11-13
60800	SUPPL	2019-11-08
49479	SUPPL	2017-08-21
49456	SUPPL	2017-08-18
48359	SUPPL	2017-05-12
48354	SUPPL	2017-05-10
48303	SUPPL	2017-05-09
48263	SUPPL	2017-05-08
33536	SUPPL	2016-04-27
15066	SUPPL	2016-04-27
33534	SUPPL	2014-12-17
988	SUPPL	2014-12-17
33535	SUPPL	2014-07-22
15065	SUPPL	2014-07-21
20140	SUPPL	2014-07-07
20139	SUPPL	2014-07-07
15064	SUPPL	2013-12-26
987	SUPPL	2013-12-26
33533	SUPPL	2013-12-24
11257	SUPPL	2013-12-24
33532	SUPPL	2013-03-26
986	SUPPL	2013-03-21
15063	SUPPL	2012-08-03
40814	SUPPL	2012-06-26
15062	SUPPL	2011-07-28
11256	SUPPL	2011-07-25
33531	SUPPL	2011-05-23
15061	SUPPL	2011-05-19
11254	SUPPL	2010-05-28
15058	SUPPL	2010-05-27
15060	SUPPL	2010-03-03
15059	SUPPL	2009-07-07
985	SUPPL	2009-07-07
33530	SUPPL	2009-07-06
11255	SUPPL	2009-07-06
15057	SUPPL	2007-08-07
33529	SUPPL	2007-08-03
40813	SUPPL	2007-06-29
984	SUPPL	2007-02-02
983	SUPPL	2006-07-13
982	SUPPL	2006-07-13
33528	SUPPL	2006-07-05
11253	SUPPL	2006-07-05
15056	SUPPL	2006-03-03
44024	ORIG	2005-07-28
11252	SUPPL	2005-01-13
981	SUPPL	2005-01-13
980	SUPPL	2004-06-01
40812	SUPPL	2003-06-17
40811	SUPPL	2003-06-17
20138	SUPPL	2003-06-17
15055	SUPPL	2002-10-22
15053	SUPPL	2002-10-02
979	SUPPL	2002-10-02
15052	SUPPL	2002-06-20
15054	SUPPL	2002-02-12
57442	ORIG	1985-12-30