Application 201567

Type: ANDA
Sponsor: ZYDUS 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	300MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201567-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2014-01-17
A201567-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201567-001	AB3
A201567-002	AB3

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 3 · 84 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	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201567-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201567-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201567-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201567-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201567-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201567-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201567-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201567-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201567-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201567-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201567-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201567-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201567-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201567-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201567-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201567-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201567-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201567-002	AB3	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion	BUPROPION	Zydus Lifesciences Limited	78d34aad-9d4f-48c4-91eb-536e31c6b6c9	2024-11-26		Exact identifier application applno (ANDA): 201567 application number: ANDA201567 ndc (product): 65841-780 ndc (product): 65841-836
bupropion	BUPROPION	Zydus Pharmaceuticals USA Inc.	8d937ca3-3351-40f1-8192-348ba0c68162	2024-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201567 application number: ANDA201567 ndc (product): 68382-353 ndc (product): 68382-354
bupropion	BUPROPION	Proficient Rx LP	47ceb7e1-b2f7-47f8-8b6a-85eea36606b8	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201567 application number: ANDA201567 ndc (product): 63187-521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63187-521	bupropion	bupropion	Proficient Rx LP	ANDA	Current
63187-521	bupropion	bupropion	Proficient Rx LP	ANDA	Current
63187-521	bupropion	bupropion	Proficient Rx LP	ANDA	Current
65841-780	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-780	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-780	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-780	bupropion	bupropion	Zydus Lifesciences Limited	ANDA	Current
65841-780	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-836	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-836	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-836	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
65841-836	bupropion	bupropion	Zydus Lifesciences Limited	ANDA	Current
65841-836	bupropion	bupropion	Cadila Healthcare Limited	ANDA	Current
68001-264	bupropion	bupropion	BluePoint Laboratories	ANDA	Current
68382-353	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-353	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-353	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-353	bupropion	bupropion	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-353	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-353	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-354	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-354	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-354	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-354	bupropion	bupropion	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-354	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-354	bupropion	bupropion	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-9255	bupropion	bupropion	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53551	ORIG	1900-01-01
53550	ORIG	1900-01-01
53548	ORIG	1900-01-01
53547	ORIG	1900-01-01
53545	ORIG	1900-01-01