Application 020358

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	50MG	No	No
002	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	No
003	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	Yes	No
004	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020358-001	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04
N020358-002	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04
N020358-003	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04
N020358-004	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020358-002	AB1
N020358-003	AB1
N020358-004	AB1

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	N020358-004	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020358-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020358-003	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020358-004	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020358-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020358-003	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020358-004	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020358-002	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020358-003	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020358-004	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020358-002	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020358-003	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020358-004	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020358-002	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020358-003	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020358-004	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020358-002	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020358-003	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020358-004	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020358-002	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020358-003	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020358-004	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020358-002	AB1	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020358-003	AB1	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020358-004	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020358-002	AB1	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020358-003	AB1	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020358-004	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020358-002	AB1	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020358-003	AB1	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020358-004	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020358-002	AB1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020358-003	AB1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020358-004	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020358-002	AB1	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020358-003	AB1	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020358-004	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020358-002	AB1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020358-003	AB1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020358-004	AB1	1	`f41ea6bd6efb…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	GlaxoSmithKline LLC	cbc8c074-f080-4489-a5ae-207b5fadeba3	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020358 application number: NDA020358 ndc (product): 0173-0135 ndc (product): 0173-0722 ndc (product): 0173-0947

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0135	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0722	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0947	WELLBUTRIN	bupropion hydrochloride	GlaxoSmithKline LLC	NDA	Current
70518-0639	WELLBUTRIN	bupropion hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0639	WELLBUTRIN	bupropion hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84105	SUPPL	2025-11-06
84104	SUPPL	2025-11-06
84079	SUPPL	2025-11-06
78427	SUPPL	2024-05-08
78419	SUPPL	2024-05-07
72875	SUPPL	2022-12-13
72819	SUPPL	2022-12-07
65002	SUPPL	2020-10-23
65001	SUPPL	2020-10-23
64972	SUPPL	2020-10-22
60831	SUPPL	2019-11-13
60830	SUPPL	2019-11-13
60801	SUPPL	2019-11-08
49480	SUPPL	2017-08-21
49458	SUPPL	2017-08-18
48360	SUPPL	2017-05-12
48352	SUPPL	2017-05-10
48304	SUPPL	2017-05-09
48265	SUPPL	2017-05-08
34548	SUPPL	2016-04-27
24832	SUPPL	2016-04-27
24831	SUPPL	2014-12-17
12474	SUPPL	2014-12-17
12475	SUPPL	2014-07-22
2385	SUPPL	2014-07-21
41299	SUPPL	2014-07-07
20610	SUPPL	2014-07-07
24830	SUPPL	2013-12-26
2384	SUPPL	2013-12-26
34547	SUPPL	2013-12-24
12473	SUPPL	2013-12-24
34546	SUPPL	2013-03-26
2383	SUPPL	2013-03-21
2382	SUPPL	2012-08-03
41298	SUPPL	2012-06-26
41297	SUPPL	2011-12-09
41296	SUPPL	2011-12-09
41295	SUPPL	2011-12-09
20607	SUPPL	2011-12-09
24829	SUPPL	2011-07-28
34545	SUPPL	2011-07-25
34544	SUPPL	2011-05-23
34540	SUPPL	2011-05-23
24828	SUPPL	2011-05-19
2378	SUPPL	2011-05-19
34543	SUPPL	2010-05-28
24826	SUPPL	2010-05-27
2381	SUPPL	2010-03-03
24827	SUPPL	2009-07-07
2380	SUPPL	2009-07-07
12472	SUPPL	2009-07-06
12471	SUPPL	2009-07-06
24825	SUPPL	2007-08-07
12470	SUPPL	2007-08-03
20609	SUPPL	2007-06-29
20608	SUPPL	2007-04-09
34542	SUPPL	2007-02-02
24824	SUPPL	2007-02-02
2379	SUPPL	2006-07-13
2377	SUPPL	2006-07-13
34541	SUPPL	2006-07-05
34539	SUPPL	2006-07-05
2376	SUPPL	2006-03-03
23578	ORIG	2005-07-28
24823	SUPPL	2005-01-13
12469	SUPPL	2005-01-13
2375	SUPPL	2004-06-01
24822	SUPPL	2004-04-29
2374	SUPPL	2002-10-22
24819	SUPPL	2002-10-02
2372	SUPPL	2002-10-02
24821	SUPPL	2002-07-12
2373	SUPPL	2002-06-20
24820	SUPPL	2002-06-14
12468	SUPPL	2002-06-14
34538	SUPPL	2001-06-11
24818	SUPPL	2001-06-11
20606	SUPPL	2001-06-11
41294	SUPPL	1997-12-16
20605	SUPPL	1997-12-16