Application 022108

Type: NDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APLENZIN	BUPROPION HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	174MG	Yes	No
002	APLENZIN	BUPROPION HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	348MG	Yes	No
003	APLENZIN	BUPROPION HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	522MG	Yes	Yes

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

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
N022108-001	APLENZIN	BUPROPION HYDROBROMIDE	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23
N022108-002	APLENZIN	BUPROPION HYDROBROMIDE	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23
N022108-003	APLENZIN	BUPROPION HYDROBROMIDE	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N022108-001	7241805	2026-06-27		Drug product
N022108-001	7569610	2026-06-27	U-997
N022108-001	7572935	2026-06-27		Drug product
N022108-001	7585897	2026-06-27		Drug product
N022108-001	7645802	2026-06-27		Drug product
N022108-001	7649019	2026-06-27		Drug product
N022108-001	7662407	2026-06-27		Drug product
N022108-001	7671094	2026-06-27		Drug product
N022108-002	7241805	2026-06-27		Drug product
N022108-002	7569610	2026-06-27	U-997
N022108-002	7572935	2026-06-27		Drug product
N022108-002	7585897	2026-06-27		Drug product
N022108-002	7645802	2026-06-27		Drug product
N022108-002	7649019	2026-06-27		Drug product
N022108-002	7662407	2026-06-27		Drug product
N022108-002	7671094	2026-06-27		Drug product
N022108-003	7241805	2026-06-27		Drug product
N022108-003	7569610	2026-06-27	U-997
N022108-003	7572935	2026-06-27		Drug product
N022108-003	7585897	2026-06-27		Drug product
N022108-003	7645802	2026-06-27		Drug product
N022108-003	7649019	2026-06-27		Drug product
N022108-003	7662407	2026-06-27		Drug product
N022108-003	7671094	2026-06-27		Drug product

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 984 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022108-001	7241805	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7569610	2026-06-27	U-997		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7572935	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7585897	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7645802	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7649019	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7662407	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7671094	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7241805	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7569610	2026-06-27	U-997		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7572935	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7585897	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7645802	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7649019	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7662407	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7671094	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7241805	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7569610	2026-06-27	U-997		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7572935	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7585897	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7645802	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7649019	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7662407	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7671094	2026-06-27		Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7241805	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7569610	2026-06-27	U-997		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7572935	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7585897	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7645802	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7649019	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7662407	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7671094	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7241805	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7569610	2026-06-27	U-997		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7572935	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7585897	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7645802	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7649019	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7662407	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7671094	2026-06-27		Drug product	`31067a03dcf5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrobromide	BUPROPION HYDROBROMIDE	Oceanside Pharmaceuticals	3ec04240-baef-44d7-8d73-a181171eec43	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022108 application number: NDA022108
Aplenzin	BUPROPION HYDROBROMIDE	Bausch Health US, LLC	6494d2d9-0ce4-4126-b1c7-49684395942b	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022108 application number: NDA022108 ndc (product): 0187-5811 ndc (product): 0187-5812 ndc (product): 0187-5810

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5810	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5811	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US, LLC	NDA	Current
0187-5812	Aplenzin	bupropion hydrobromide	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84109	SUPPL	2025-11-06
84108	SUPPL	2025-11-06
84086	SUPPL	2025-11-06
78437	SUPPL	2024-05-08
78421	SUPPL	2024-05-07
70496	SUPPL	2022-03-11
70495	SUPPL	2022-03-11
70439	SUPPL	2022-03-09
68068	SUPPL	2021-07-13
68067	SUPPL	2021-07-13
68042	SUPPL	2021-07-12
62819	SUPPL	2020-05-05
62813	SUPPL	2020-05-04
62812	SUPPL	2020-05-04
48300	SUPPL	2017-05-09
48259	SUPPL	2017-05-05
48256	SUPPL	2017-05-05
45216	SUPPL	2016-08-30
45187	SUPPL	2016-08-30
38261	SUPPL	2015-01-09
6906	SUPPL	2015-01-07
16956	SUPPL	2014-07-11
29263	SUPPL	2014-07-10
29262	SUPPL	2012-08-17
16955	SUPPL	2012-08-15
29261	SUPPL	2011-07-28
29260	SUPPL	2011-07-28
38260	SUPPL	2011-07-27
16954	SUPPL	2011-07-27
29259	SUPPL	2011-05-04
6905	SUPPL	2011-05-04
16953	SUPPL	2011-05-02
42417	ORIG	2009-04-07
24242	ORIG	2009-04-07
16952	ORIG	2008-05-27
6904	ORIG	2008-04-24