Application 079094

Type: ANDA
Sponsor: ACTAVIS LABS FL 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	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079094-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079094-001	AB2

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2009-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079094-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2009-03-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A079094-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079094-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079094-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079094-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079094-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079094-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079094-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079094-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079094-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079094-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079094-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079094-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079094-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079094-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079094-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079094-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079094-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079094-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079094-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079094-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079094-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079094-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079094-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079094-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079094-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079094-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079094-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079094-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079094-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079094-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079094-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079094-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079094-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079094-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079094-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079094-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079094-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079094-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079094-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079094-001	AB2	1	`e64feba35796…`

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 SR	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	a591e33a-52f0-41c8-a00b-4a1afcc3dc4c	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079094 application number: ANDA079094 ndc (product): 0591-3543
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	dfb45438-1116-48f2-9bfe-776ebbf1e119	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079094 application number: ANDA079094 ndc (product): 50090-1150

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3543	Bupropion Hydrochloride	bupropion hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3543	Bupropion Hydrochloride	bupropion hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3543	Bupropion Hydrochloride	bupropion hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3543	Bupropion Hydrochloride	bupropion hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3543	Bupropion Hydrochloride	bupropion hydrochloride	Actavis Pharma, Inc.	ANDA	Current
50090-1150	Bupropion Hydrochloride	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1150	Bupropion Hydrochloride	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1150	Bupropion Hydrochloride	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current