Application 211347

Type: ANDA
Sponsor: YICHANG HUMANWELL

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 1.

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	TE codes	Approval date
A211347-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16
A211347-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16
A211347-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211347-001	AB1
A211347-002	AB1
A211347-003	AB1

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211347-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211347-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211347-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-10-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211347-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211347-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211347-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211347-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211347-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211347-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211347-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211347-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211347-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211347-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211347-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211347-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211347-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211347-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211347-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211347-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211347-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211347-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211347-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211347-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211347-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211347-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211347-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211347-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211347-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211347-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211347-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211347-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211347-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211347-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211347-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211347-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211347-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211347-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211347-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211347-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211347-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211347-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211347-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211347-001	AB1	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Epic Pharma, LLC	f8ad76a2-9f75-4660-973d-34402f314e9c	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211347 application number: ANDA211347
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	f2b3939b-a410-6354-e053-2995a90ababb	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211347 application number: ANDA211347
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	500fc18d-93b4-47d5-a3f7-3f68822d83e8	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211347 application number: ANDA211347 ndc (product): 71335-1986
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	634bc654-be95-4fea-b308-eed53269a112	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211347 application number: ANDA211347 ndc (product): 71335-1870
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	0574b84d-075f-410f-a8eb-86901e307ea2	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211347 application number: ANDA211347 ndc (product): 71335-1837
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	7c4313fa-bb29-dd50-e053-2991aa0a3005	2024-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211347 application number: ANDA211347 ndc (product): 70436-059 ndc (product): 70436-060 ndc (product): 70436-058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7214	Bupropion Hydrochloride	bupropion hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7214	Bupropion Hydrochloride	bupropion hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7270	Bupropion Hydrochloride	bupropion hydrochloride	Major Pharmaceuticals	ANDA	Current
55700-895	Bupropion Hydrochloride	bupropion hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-895	Bupropion Hydrochloride	bupropion hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-895	Bupropion Hydrochloride	bupropion hydrochloride	Quality Care Products, LLC	ANDA	Current
70436-058	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-058	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-058	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-058	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-058	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-059	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-059	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-059	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-059	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-059	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-060	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-060	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-060	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-060	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-060	Bupropion Hydrochloride	bupropion hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70518-3058	Bupropion Hydrochloride	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3058	Bupropion Hydrochloride	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3058	Bupropion Hydrochloride	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3079	Bupropion Hydrochloride	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3079	Bupropion Hydrochloride	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-985	Bupropion Hydrochloride	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-985	Bupropion Hydrochloride	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1837	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1837	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1870	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1870	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1870	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1986	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1986	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current