Application 215568

Type: ANDA
Sponsor: GRANULES

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 1.

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
A215568-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-02-02
A215568-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215568-001	AB3
A215568-002	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 2 · 64 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	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A215568-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215568-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215568-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215568-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215568-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215568-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215568-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215568-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215568-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215568-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215568-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215568-002	AB3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215568-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215568-002	AB3	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-001	AB3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-002	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215568-001	AB3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215568-002	AB3	1	`1c564ffb4f44…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c60855ca-4fa0-4004-ad19-4abb61100c43	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	bf5e933c-8a84-4dd7-a05d-6c4a82b6c965	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Unit Dose Solutions, Inc.	53c192ca-ac51-cb87-e063-6394a90a6c08	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	f1703bfd-be36-4fde-8e67-df0fb5d93369	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d9eb0939-63c1-48c4-a444-a899d7924d06	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568 ndc (product): 70010-785 ndc (product): 70010-784
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	4956af38-182a-4015-a945-67e40bd38772	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	487271f1-c956-086a-e063-6394a90a2dc7	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	069e6828-e599-4614-9645-9cf1382ac93e	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	82872e51-3349-40fe-8ea3-496751955fed	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	e47df78d-5e9b-485d-8d92-0e00602f7a31	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	2ccbf988-64b6-3a60-e063-6394a90ababa	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1724f474-d6ab-46af-940f-7f874d4ff7fc	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70010-784	Bupropion hydrochloride	Bupropion hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current
70010-785	Bupropion hydrochloride	Bupropion hydrochloride	Granules Pharmaceuticals Inc.	ANDA	Current