Application 090941

Type: ANDA
Sponsor: MYLAN

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 43.

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
A090941-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2010-05-03

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 · 43 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
2026-09-14 22:38:34	2026-08	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2010-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2010-05-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2010-05-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090941-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-05-03	`f41ea6bd6efb…`

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	A090941-001	AB2	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A090941-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090941-001	AB2	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 3 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	82bcdd72-9146-4c8d-a8aa-f92015864605	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	eb25adb1-9841-42ce-aa22-718fb0fba5dd	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	8499470a-8d01-4348-b67b-8f49728031cb	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	5c111cf0-0199-4a4d-8138-81579af4c14d	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	4c9a5dc3-bebe-431a-b550-ce46c6c6b01e	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Unit Dose Solutions, Inc.	53c192ca-ac51-cb87-e063-6394a90a6c08	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	434aacf8-87f1-44fc-a66b-92ae0022de0e	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	f1703bfd-be36-4fde-8e67-df0fb5d93369	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	cefaaa17-f79a-4ba6-8f97-a59f60e07b75	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f58ce435-b124-4519-98d8-de2d00f61b01	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b5c12c9a-62eb-481a-8099-7ad35242f7bf	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	6701af43-bf7d-45c4-a331-a18d16bd68f7	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amici Pharma, Inc.	fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c75	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	21be6b3b-add3-43e7-af93-30350aefc89e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a72db723-df4b-4bf4-9bdc-05ae82058696	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Coupler LLC	512b0ed3-db7d-b273-e063-6394a90a25cc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	507112bd-a082-e85a-e063-6294a90ab2ac	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	64934ca2-5655-45a2-9016-ad65b5abf5d3	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5521	Bupropion Hydrochloride	Bupropion Hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current