Application 075644

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	TABLET;ORAL	5MG	No	No
002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	TABLET;ORAL	10MG	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
A075644-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL			2001-06-26
A075644-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL			2001-06-26

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	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2001-06-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2001-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2001-06-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2001-06-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075644-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075644-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075644-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075644-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075644-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075644-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075644-002	AB	1	`ea99ee380514…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	f6ce8f14-43fc-4c5e-8378-62ca7121e918	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	428ef54d-8828-4756-a087-a1b7b2d6b8d6	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Viona Pharmaceuticals Inc	3c393b41-9423-4ea6-8a79-0cbff0693471	2023-11-10	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	4f11e64c-732e-419a-bc29-9cd2ff86d0b9	2023-09-22	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol fumarate	BISOPROLOL FUMARATE	Solco Healthcare US, LLC	084308e4-3b8b-40d6-acbf-d775772a8a73	2023-06-26	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol fumarate generic name: BISOPROLOL FUMARATE
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Limited	ae10b8e1-557d-4437-8a1d-89d7844122c8	2023-02-07	Warnings, Adverse reactions	Name fallback brand name: BISOPROLOL FUMARATE generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Unichem Pharmaceuticals (USA), Inc.	4f20df45-3f9c-4a91-b394-e93a08111ec3	2022-10-28	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Novitium Pharma LLC	6517d564-ea55-4084-a8ab-34fea548c24e	2021-11-05	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	9b2eb4ea-001e-436c-93ba-20a7f5bc5f04	2021-10-08	Warnings, Adverse reactions	Name fallback brand name: BISOPROLOL FUMARATE generic name: BISOPROLOL FUMARATE
Bisoprolol	BISOPROLOL FUMARATE	TruPharma, LLC	bba0bc2b-602f-4df1-a761-85bd3c80c7de	2021-01-14	Warnings, Adverse reactions	Name fallback generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Proficient Rx LP	bce7e65a-148f-4ccd-9305-bc7331dbcca4	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5270	Bisoprolol Fumarate	Bisoprolol Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5271	Bisoprolol Fumarate	Bisoprolol Fumarate	Teva Pharmaceuticals USA, Inc.	ANDA	Current