Application 201331

Type: ANDA
Sponsor: WOCKHARDT LTD

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 43.

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
A201331-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30
A201331-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30
A201331-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`301d65b070ca…`

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 6 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	f2b3939b-a410-6354-e053-2995a90ababb	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	487271f1-c956-086a-e063-6394a90a2dc7	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	4ddf6ba2-c020-7912-e063-6394a90a7964	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	990587bd-4c7d-4a36-8a38-3104648ab3a2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Coupler LLC	47b96919-a8ea-b769-e063-6394a90aa34e	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	90cc4f07-e0a3-4d50-a10a-8f6a7f9c5140	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	ab6cd2ea-507c-35e5-e053-2a95a90ac5cb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	d9bbacb3-63b4-2922-e053-2a95a90a6085	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	f2b30440-0e07-2670-e053-2995a90afa28	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Lannett Company Inc.	15c4e95a-d203-4caf-b6c7-44792355cb76	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Vitruvias Therapeutics	f53704b2-3d3c-47e8-9fd6-a0f5240c0593	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	459bd1c9-d7a5-8bc9-e063-6394a90a8ecd	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	458c8a67-4995-c772-e063-6394a90a1f8d	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	45789ff4-af5d-96b0-e063-6394a90a0644	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	7d035056-44ab-444d-9d27-125b3f571140	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Modavar Pharmaceuticals LLC	0961f83e-25e9-4ffc-8669-44e4e9169978	2025-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
buPropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Oryza pharmaceuticals Inc.	004d8121-59d4-46c4-acb8-b2dd097bf556	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Golden State Medical Supply, Inc.	9490d611-b679-45c7-e053-2a95a90afb87	2025-11-18	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	1bd2ed35-35c5-464f-bf51-9dd4b42ee59a	2025-11-14	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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-449	Bupropion Hydrochloride SR	Bupropion Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55648-101	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt Limited	ANDA	Current
55648-105	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt Limited	ANDA	Current
55648-107	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt Limited	ANDA	Current
64679-101	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-101	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-105	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-105	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-107	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-107	Bupropion Hydrochloride	Bupropion Hydrochloride	Wockhardt USA LLC.	ANDA	Current