Application 211020

Type: ANDA
Sponsor: GRAVITI 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	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
A211020-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-01-28
A211020-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211020-001	AB3
A211020-002	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	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`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	A211020-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211020-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211020-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211020-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211020-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211020-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211020-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211020-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211020-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211020-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211020-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211020-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211020-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211020-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211020-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211020-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211020-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211020-002	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	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a613cfd3-1aa1-49c5-b742-b105c97d73f1	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	136f29fa-a859-4efb-8365-1382716d6f8f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e4f4d3fa-ddf6-4125-8486-8157efc095c1	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020 ndc (product): 16571-863 ndc (product): 16571-862
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	d087222e-c5e9-4c48-b27f-e2e2944379c8	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-862	Bupropion Hydrochloride	Bupropion Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
16571-863	Bupropion Hydrochloride	Bupropion Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
58657-710	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-710	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-710	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-711	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-711	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-711	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-712	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-712	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-713	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-713	Bupropion hydrochloride	Bupropion hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
68788-8272	Bupropion hydrochloride	Bupropion hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
69844-010	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-010	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-010	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-010	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-011	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-011	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-011	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-011	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-064	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-064	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-065	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-065	bupropion hydrochloride	extended-release	Graviti Pharmaceuticals Private Limited	ANDA	Current
70377-034	bupropion hydrochloride	bupropion hydrochloride	Biocon Pharma Inc.,	ANDA	Current
70377-034	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	Biocon Pharma Inc.,	ANDA	Current
70377-034	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	Biocon Pharma Inc.,	ANDA	Current
70377-035	bupropion hydrochloride	bupropion hydrochloride	Biocon Pharma Inc.,	ANDA	Current
70377-035	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	Biocon Pharma Inc.,	ANDA	Current
70377-035	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	Biocon Pharma Inc.,	ANDA	Current