Application 206674

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	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 43.

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	Approval date
A206674-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09
A206674-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09
A206674-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A206674-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206674-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206674-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206674-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206674-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206674-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206674-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206674-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206674-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206674-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206674-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206674-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206674-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206674-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206674-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206674-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206674-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206674-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206674-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206674-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206674-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206674-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206674-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206674-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206674-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206674-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206674-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206674-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206674-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206674-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206674-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206674-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206674-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206674-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206674-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206674-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206674-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206674-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206674-003	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206674-001	AB1	1	`6a51e52b5d6a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f7	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206674 application number: ANDA206674 ndc (product): 43063-744
BUPROPION HYDROCHLORIDE (SR)	BUPROPION HYDROCHLORIDE	Cipla USA Inc.,	9d2c209b-248e-4e26-9cde-fe0abe4428c1	2018-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206674 application number: ANDA206674 ndc (product): 69097-878 ndc (product): 69097-877 ndc (product): 69097-879

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-744	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-744	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-744	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-744	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-633	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Medsource Pharmaceuticals	ANDA	Current
50090-3249	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3453	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	A-S Medication Solutions	ANDA	Current
53002-1509	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1509	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53217-252	Bupropion Hydrochloride	Bupropion Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-487	Bupropion Hydrochloride	Bupropion Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0878	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0878	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Clinical Solutions Wholesale, LLC	ANDA	Current
69097-877	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Cipla USA Inc.,	ANDA	Current
69097-878	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Cipla USA Inc.,	ANDA	Current
69097-879	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Cipla USA Inc.,	ANDA	Current
70518-1033	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1033	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-156	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-156	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-156	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0006	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0006	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0025	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0025	BUPROPION HYDROCHLORIDE (SR)	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10590	ORIG	2016-02-12