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 7 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	Aurobindo Pharma Limited	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	61e9cbe3-8211-42f3-b68f-581f56651919	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	cec41945-8d64-4793-8784-4c2b8ec37b0f	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Forfivo XL	BUPROPION HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	80b01182-dc94-4990-8ebb-55c306d7e536	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	GlaxoSmithKline LLC	cbc8c074-f080-4489-a5ae-207b5fadeba3	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	e2a988f2-f8d3-4de0-b9f1-49d8c2e4180f	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	e4c450ff-32bd-4359-8449-0b0d0b89a78c	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	722650d8-5ee4-48ba-9827-7c86b1283522	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	16ffe2ac-4f71-4843-99df-611f53c2f3cd	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f7	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Accord Healthcare Inc.	34686e9d-c106-4276-8b47-7460cca8860e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE (SR)	BUPROPION HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	8069c521-c49a-4b6d-baa8-4b0be897d585	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	a591e33a-52f0-41c8-a00b-4a1afcc3dc4c	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	6563b923-269f-40c3-b992-cbacdfca6e16	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	3eec57be-b8ae-cdf8-e063-6394a90a694d	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	b303a0ad-5971-44ab-937c-bcf3ff650358	2025-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	9196568e-aec8-4d56-993e-4cbb78d4a3a6	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	069e6828-e599-4614-9645-9cf1382ac93e	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	98d5977f-9b32-46db-bd36-a2c4d1b0710a	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d826804-6427-aae1-e063-6394a90a6593	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback 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