Application 091520

Type: ANDA
Sponsor: ANCHEN PHARMS

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

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
A091520-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2011-06-09

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2011-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091520-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2011-06-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091520-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091520-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091520-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091520-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091520-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091520-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091520-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091520-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091520-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091520-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091520-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091520-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091520-001	AB2	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A091520-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091520-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091520-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091520-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091520-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091520-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091520-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091520-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091520-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091520-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091520-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091520-001	AB2	1	`cb3db0bc1861…`

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5829a2aa-4845-b58b-e063-6294a90ad2f4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	30c370c2-f2b7-4335-ba55-e8c8f4059092	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	080853c0-fcab-4645-9ddc-4946e895ac5f	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	aa3d3e5b-74a3-47f6-b9aa-d6e248e950e5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	cc344f7c-0eb3-4e63-a09e-b682acca2bb5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c60855ca-4fa0-4004-ad19-4abb61100c43	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	eb946d81-b4f4-42e9-aa7a-31d76d15629c	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	740534d3-59b5-4938-8e38-16275a14438c	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	a1e768fd-c28f-4b49-822d-ccc315b4099c	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	1af14d2e-c64d-44b7-a402-8869e8e30661	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	9aa3753f-1a0e-4faa-995f-67e29b320737	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	b2e6c30f-a33c-4854-ab19-bc9f65880374	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a613cfd3-1aa1-49c5-b742-b105c97d73f1	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	df923448-4f81-47af-8e55-f7359746b05f	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5604eb14-bab4-4f06-e063-6294a90a6920	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	867d3876-6974-4e89-bc45-9e60e84b401c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4fbe64aa-f8f4-45fa-88ae-e844997703ae	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	362504fd-2f0a-c097-e063-6394a90ac0fc	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	American Health Packaging	88c980c8-aaa8-4378-9ac2-24d588640caa	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE