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WELLBUTRIN	BUPROPION HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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WELLBUTRIN	BUPROPION HYDROCHLORIDE	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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BUPROPION HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018644-001	WELLBUTRIN	BUPROPION HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30
N018644-002	WELLBUTRIN	BUPROPION HYDROCHLORIDE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30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WELLBUTRIN	BUPROPION HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30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N018644-001	WELLBUTRIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-12-30	`84e616aacf4f…`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 11 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	73167de9-948d-465c-88c0-c7743a79e7f5	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e	2024-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmacueticals, Inc.	15ad0c66-1829-59c3-e063-6394a90a4384	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c1fa6fce-272b-4497-a958-177f0bafdfc7	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	62d0dcb5-c70b-4884-9755-740f62a8b31a	2024-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	8ae81b03-b447-4a3f-8ed9-ebf75ee52b49	2024-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	dfd5f264-d4fd-4441-88b1-48086c7c0616	2024-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8d80f882-1887-4d73-b09f-e98fd7ef2acb	2024-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ef0bb8f2-7710-4236-8b47-57b74c8bca3e	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	dfb45438-1116-48f2-9bfe-776ebbf1e119	2023-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cipla USA., Inc.	0abd64f7-5142-48f6-a487-3f5bdc3400de	2023-10-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Proficient Rx LP	80f4a4ef-8190-458d-af2e-5daaf32abc01	2023-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b	2023-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	ec9cbb38-1582-492f-a526-4b3675c55b14	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	8a0781c0-e7d5-498e-b7d3-d6bd457f175f	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a	2023-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b0e10a21-0ae3-4a8b-bd3e-7a48b30f8418	2023-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	CIPLA USA INC.,	e4100232-a25d-4468-9057-af7e66205154	2023-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	6948f63b-599c-4956-a249-e9544beda9fc	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	5e568bb5-542a-4395-a21e-dc64281d694e	2022-11-01	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