Application 207224

Type: ANDA
Sponsor: ANBISON LAB

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
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	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
A207224-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-06-30
A207224-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207224-001	AB3
A207224-002	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	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207224-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207224-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-06-30	`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	A207224-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207224-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207224-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207224-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207224-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207224-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207224-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207224-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207224-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207224-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207224-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207224-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207224-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207224-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207224-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207224-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207224-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207224-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207224-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207224-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207224-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207224-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207224-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207224-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207224-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207224-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207224-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207224-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207224-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207224-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207224-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207224-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207224-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207224-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207224-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207224-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207224-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207224-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207224-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207224-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	ed27c415-9f29-4789-9da4-4a14aaba95bd	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207224 application number: ANDA207224
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2aabf040-16a6-b772-e063-6294a90afd70	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207224 application number: ANDA207224
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	c280efb9-b284-6a69-e053-2995a90a3035	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207224 application number: ANDA207224 ndc (product): 69367-289 ndc (product): 69367-288
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	5e568bb5-542a-4395-a21e-dc64281d694e	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207224 application number: ANDA207224 ndc (product): 71205-291
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Epic Pharma, LLC	178c7129-a752-4ad9-ac82-4473e23bbacc	2021-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207224 application number: ANDA207224 ndc (product): 42806-348 ndc (product): 42806-349

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-348	Bupropion Hydrochloride	Bupropion Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-348	Bupropion Hydrochloride	Bupropion Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-348	Bupropion Hydrochloride	Bupropion Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-349	Bupropion Hydrochloride	Bupropion Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-349	Bupropion Hydrochloride	Bupropion Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-349	Bupropion Hydrochloride	Bupropion Hydrochloride	Epic Pharma, LLC	ANDA	Current
61919-674	BUPROPION HCL ER	BUPROPION HCL ER	DIRECT RX	ANDA	Current
61919-674	BUPROPION HCL ER	BUPROPION HCL ER	Direct_Rx	ANDA	Current
63629-7820	Bupropion Hydrochloride	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7820	Bupropion Hydrochloride	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-7479	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7479	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7509	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7509	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7509	Bupropion Hydrochloride	Bupropion Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69367-288	Bupropion Hydrochloride	Bupropion Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-288	Bupropion Hydrochloride	Bupropion Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-289	Bupropion Hydrochloride	Bupropion Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-289	Bupropion Hydrochloride	Bupropion Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-291	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
71205-291	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
71205-291	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current
71205-291	Bupropion Hydrochloride	Bupropion Hydrochloride	Proficient Rx LP	ANDA	Current