Application 021515

Type: NDA
Sponsor: VALEANT INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	Yes	No
002	WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021515-001	WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28
N021515-002	WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021515-001	AB3
N021515-002	AB3

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021515-001	WELLBUTRIN XL	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2003-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021515-002	WELLBUTRIN XL	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2003-08-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021515-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021515-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021515-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021515-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021515-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021515-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021515-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021515-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021515-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021515-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021515-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021515-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021515-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021515-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021515-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021515-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021515-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021515-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021515-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021515-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021515-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021515-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021515-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021515-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021515-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021515-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021515-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021515-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021515-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021515-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021515-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021515-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021515-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021515-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021515-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021515-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021515-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021515-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021515-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021515-002	AB3	1	`782e0a99824c…`

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 XL	BUPROPION HYDROCHLORIDE	Bausch Health US LLC	a435da9d-f6e8-4ddc-897d-8cd2bf777b21	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021515 application number: NDA021515 ndc (product): 0187-0730 ndc (product): 0187-0731

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0730	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
0187-0731	WELLBUTRIN	bupropion hydrochloride	Bausch Health US LLC	NDA	Current
21695-137	WELLBUTRIN XL	bupropion hydrochloride	Rebel Distributors Corp	NDA	Current
21695-138	WELLBUTRIN XL	bupropion hydrochloride	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84111	SUPPL	2025-11-06
84110	SUPPL	2025-11-06
84085	SUPPL	2025-11-06
78436	SUPPL	2024-05-08
78435	SUPPL	2024-05-08
78422	SUPPL	2024-05-07
70494	SUPPL	2022-03-11
70493	SUPPL	2022-03-11
70438	SUPPL	2022-03-09
68066	SUPPL	2021-07-13
68065	SUPPL	2021-07-13
68041	SUPPL	2021-07-12
61006	SUPPL	2019-11-20
61005	SUPPL	2019-11-20
60794	SUPPL	2019-11-08
48299	SUPPL	2017-05-09
48258	SUPPL	2017-05-05
48257	SUPPL	2017-05-05
45206	SUPPL	2016-08-30
45188	SUPPL	2016-08-30
5600	SUPPL	2015-01-07
5599	SUPPL	2015-01-07
37124	SUPPL	2015-01-05
15656	SUPPL	2015-01-05
28004	SUPPL	2014-07-15
15657	SUPPL	2014-07-15
28003	SUPPL	2012-08-03
28002	SUPPL	2011-07-28
5598	SUPPL	2011-07-28
37123	SUPPL	2011-07-27
15655	SUPPL	2011-07-27
15653	SUPPL	2010-05-28
27999	SUPPL	2010-05-27
37122	SUPPL	2009-07-09
15654	SUPPL	2009-07-09
28001	SUPPL	2009-07-08
28000	SUPPL	2009-07-08
27998	SUPPL	2007-08-07
15652	SUPPL	2007-08-03
21709	SUPPL	2007-06-29
5597	SUPPL	2006-07-13
37120	SUPPL	2006-07-05
37121	SUPPL	2006-06-14
27997	SUPPL	2006-06-14
27995	SUPPL	2006-06-14
15651	SUPPL	2006-06-14
27996	SUPPL	2006-03-03
23668	ORIG	2005-07-28
42198	ORIG	2005-04-27
27994	SUPPL	2005-01-13
15650	SUPPL	2005-01-13
5596	SUPPL	2004-10-29
27993	SUPPL	2004-06-01
37119	ORIG	2003-09-09
5595	ORIG	2003-09-09