Application 076711

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076711-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2004-12-03

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 · 41 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	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076711-001	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076711-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076711-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076711-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076711-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076711-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076711-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076711-001	AB1	1	`ea99ee380514…`

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
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	e962fb9a-d9fb-49c5-a8b4-0b355b8f829b	2024-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076711 application number: ANDA076711 ndc (product): 0115-5445

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44318	ORIG	2005-07-28