Application 077285

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077285-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2008-11-26
A077285-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2008-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077285-001	AB3
A077285-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077285-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077285-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2008-08-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077285-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077285-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077285-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077285-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077285-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077285-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077285-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077285-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077285-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077285-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077285-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077285-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077285-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077285-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077285-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077285-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077285-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077285-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077285-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077285-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077285-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077285-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077285-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077285-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077285-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077285-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077285-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077285-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077285-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077285-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077285-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077285-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077285-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077285-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077285-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077285-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077285-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077285-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077285-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077285-002	AB3	1	`bb7c543d1eb4…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	df923448-4f81-47af-8e55-f7359746b05f	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077285 application number: ANDA077285 ndc (product): 45963-142
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	HAWAII REPACK, INC.	b4a1d3b8-afcf-47e3-96d3-469d8f408a31	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077285 application number: ANDA077285
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Asclemed USA, Inc.	637e89e5-8f6e-4392-8045-a778cb9ed138	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077285 application number: ANDA077285
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	9e2d9c1e-a1de-491d-8f64-34ae60419611	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077285 application number: ANDA077285 ndc (product): 63187-819

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-749	Bupropion Hydrochloride	Bupropion Hydrochloride	medsource pharmaceuticals	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
45963-142	Bupropion Hydrochloride	Bupropion Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
50090-2721	Bupropion Hydrochloride	Bupropion Hydrochloride	A-S Medication Solutions	ANDA	Current
53002-2508	Bupropion Hydrochloride	Bupropion Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-254	Bupropion Hydrochloride	Bupropion Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-257	Bupropion Hydrochloride	Bupropion Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-358	Bupropion Hydrochloride	Bupropion Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-358	Bupropion Hydrochloride	Bupropion Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-358	Bupropion Hydrochloride	Bupropion Hydrochloride	Golden State Medical Supply	ANDA	Current
63187-728	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-819	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-819	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-819	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-819	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-819	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
68788-7221	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7221	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7221	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0227	Bupropion Hydrochloride	Bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-758	Bupropion Hydrochloride	Bupropion Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0331	Bupropion Hydrochloride	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0331	Bupropion Hydrochloride	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0331	Bupropion Hydrochloride	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-131	Bupropion Hydrochloride	Bupropion Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22600	ORIG	2011-08-09