Application 206556

Type: ANDA
Sponsor: INVAGEN 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 43.

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
A206556-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2016-08-26
A206556-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2016-08-26

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 · 86 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
2026-09-14 22:38:34	2026-08	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206556-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206556-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206556-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206556-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206556-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206556-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206556-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206556-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206556-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206556-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206556-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206556-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206556-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206556-002	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206556-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206556-002	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206556-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206556-002	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206556-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206556-002	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206556-001	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206556-002	AB3	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206556-001	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206556-002	AB3	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206556-001	AB3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206556-002	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206556-001	AB3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206556-002	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206556-001	AB3	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206556-002	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206556-001	AB3	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206556-002	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206556-001	AB3	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206556-002	AB3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206556-001	AB3	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206556-002	AB3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206556-001	AB3	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206556-002	AB3	1	`3f0d92c62455…`

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 Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Proficient Rx LP	80f4a4ef-8190-458d-af2e-5daaf32abc01	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206556 application number: ANDA206556
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	8a0781c0-e7d5-498e-b7d3-d6bd457f175f	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206556 application number: ANDA206556 ndc (product): 76282-481 ndc (product): 76282-480
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	CIPLA USA INC.,	c2cf79d7-1aba-4391-980b-5e218781f7c6	2020-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206556 application number: ANDA206556 ndc (product): 69097-875 ndc (product): 69097-876

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8179	Bupropion Hydrochloride	bupropion hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8179	Bupropion Hydrochloride	bupropion hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8241	Bupropion Hydrochloride	bupropion hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8241	Bupropion Hydrochloride	bupropion hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
61919-069	BUPROPION HYDROCHLORIDE (XL)	BUPROPION HYDROCHLORIDE (XL)	DIRECT RX	ANDA	Current
61919-069	BUPROPION HYDROCHLORIDE (XL)	BUPROPION HYDROCHLORIDE (XL)	DIRECT RX	ANDA	Current
67046-081	Bupropion Hydrochloride	bupropion hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
68001-321	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-321	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-321	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-321	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-322	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-322	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-322	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68001-322	Bupropion Hydrochloride	bupropion hydrochloride	BluePoint Laboratories	ANDA	Current
68788-6809	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6809	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6931	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6931	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7756	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7756	Bupropion Hydrochloride	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69097-875	Bupropion Hydrochloride	bupropion hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-875	Bupropion Hydrochloride	bupropion hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-876	Bupropion Hydrochloride	bupropion hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-876	Bupropion Hydrochloride	bupropion hydrochloride	CIPLA USA INC.,	ANDA	Current
70518-0436	Bupropion Hydrochloride	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-076	Bupropion Hydrochloride	bupropion hydrochloride	Proficient Rx LP	ANDA	Current
71205-076	Bupropion Hydrochloride	bupropion hydrochloride	Proficient Rx LP	ANDA	Current
71335-0313	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0313	Bupropion Hydrochloride	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
76282-480	Bupropion Hydrochloride	bupropion hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-480	Bupropion Hydrochloride	bupropion hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-480	Bupropion Hydrochloride	bupropion hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-481	Bupropion Hydrochloride	bupropion hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-481	Bupropion Hydrochloride	bupropion hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-481	Bupropion Hydrochloride	bupropion hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76519-1021	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	H.J. Harkins Company Inc.	ANDA	Current