Application 078866

Type: ANDA
Sponsor: SUN PHARM

Application Products#

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

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	Approval date
A078866-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2010-04-06
A078866-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2010-04-06
A078866-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2010-04-06

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078866-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078866-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078866-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078866-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078866-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078866-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078866-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078866-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078866-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078866-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078866-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078866-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078866-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078866-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078866-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078866-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078866-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078866-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078866-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078866-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078866-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078866-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078866-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078866-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078866-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078866-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078866-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078866-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078866-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078866-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078866-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078866-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078866-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078866-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078866-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078866-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078866-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078866-003	AB1	1	`b00525d2431f…`

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 hydrochloride	BUPROPION HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	29848192-7de3-4c0d-a822-1268dcf128b0	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078866 application number: ANDA078866 ndc (product): 47335-736 ndc (product): 47335-738 ndc (product): 47335-737
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	d4272e3f-78ee-4d80-b911-e840fb14acbe	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078866 application number: ANDA078866 ndc (product): 63187-178 ndc (product): 63187-052 ndc (product): 63187-176

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-797	Bupropion hydrochloride	Bupropion hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-364	Bupropion hydrochloride	Bupropion hydrochloride	RxChange Co.	ANDA	Current
47335-736	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-736	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-736	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-737	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-737	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-737	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-738	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-738	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-738	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-0862	Bupropion hydrochloride	Bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0862	Bupropion hydrochloride	Bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
51655-003	Bupropion Hydrochloride	Bupropion Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
61919-036	WELLBUTRIN SR	BUPROPION HCL ER (SR)	DIRECT RX	ANDA	Current
61919-038	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-038	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-052	Bupropion hydrochloride	Bupropion hydrochloride	Proficient Rx LP	ANDA	Current
63187-052	Bupropion hydrochloride	Bupropion hydrochloride	Proficient Rx LP	ANDA	Current
63187-176	Bupropion hydrochloride	Bupropion hydrochloride	Proficient Rx LP	ANDA	Current
63187-176	Bupropion hydrochloride	Bupropion hydrochloride	Proficient Rx LP	ANDA	Current
63187-178	Bupropion hydrochloride	Bupropion hydrochloride	Proficient Rx LP	ANDA	Current
63187-178	Bupropion hydrochloride	Bupropion hydrochloride	Proficient Rx LP	ANDA	Current
64725-0736	Bupropion hydrochloride	Bupropion hydrochloride	TYA Pharmaceuticals	ANDA	Current
64725-0737	Bupropion hydrochloride	Bupropion hydrochloride	TYA Pharmaceuticals	ANDA	Current
68258-7157	Bupropion hydrochloride	Bupropion hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
70518-3551	Bupropion hydrochloride	Bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current