Application 207389

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;ORAL	75MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207389-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL			2017-09-18
A207389-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL			2017-09-18

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`3a93d1ddd44b…`

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	A207389-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207389-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207389-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207389-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207389-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207389-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207389-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207389-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207389-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207389-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207389-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207389-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207389-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207389-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207389-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207389-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207389-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207389-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207389-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207389-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207389-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207389-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207389-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207389-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207389-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207389-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207389-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-002	AB	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 · 2 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	c1fa6fce-272b-4497-a958-177f0bafdfc7	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207389 application number: ANDA207389 ndc (product): 71335-0877
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	CIPLA USA INC.,	e4100232-a25d-4468-9057-af7e66205154	2023-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207389 application number: ANDA207389 ndc (product): 69097-917 ndc (product): 69097-918

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-7319	bupropion Hydrochloride	bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7319	bupropion Hydrochloride	bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7319	bupropion Hydrochloride	bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
69097-917	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-917	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-917	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-917	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-918	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-918	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-918	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
69097-918	bupropion Hydrochloride	bupropion Hydrochloride	CIPLA USA INC.,	ANDA	Current
70518-2427	bupropion Hydrochloride	bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2427	bupropion Hydrochloride	bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2463	bupropion Hydrochloride	bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2463	bupropion Hydrochloride	bupropion Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0877	bupropion Hydrochloride	bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0877	bupropion Hydrochloride	bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0877	bupropion Hydrochloride	bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0943	bupropion Hydrochloride	bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0943	bupropion Hydrochloride	bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current