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 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
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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075644-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	2001-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075644-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	2001-06-26	`c2088c7a36db…`
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…`

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 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Golden State Medical Supply, Inc.	df37d337-9978-0c31-e053-2a95a90a3258	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	6ebe6ec0-6223-425c-9f3b-8ab8dd8b3f5f	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Preferred Pharmaceuticals Inc.	c0e309f3-82c3-4629-b790-fb8538b87369	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol	BISOPROLOL FUMARATE	Micro Labs Limited	c3ee566c-74c4-45f4-a947-526a7313e326	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Advagen Pharma Ltd	83e4b4e5-9130-44c8-abab-fcd0db5d8c49	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Rising Pharma Holdings, Inc.	200ab93b-6ad3-46cb-8f57-db056a14de16	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	TruPharma LLC	0ef9e45c-21ee-4e00-a9b8-280e2035b4d3	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol fumarate	BISOPROLOL FUMARATE	Natco Pharma USA LLC	e907bfcb-5e64-45b8-ae9d-822b3d360104	2025-01-24	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	American Health Packaging	36b53e7f-e306-40a8-8d1b-d00695a4fe61	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Zydus Lifesciences Limited	2d380e61-052c-4c33-8a35-01c9eb651d68	2024-08-14		Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	NorthStar Rx LLC	4bf3278c-116f-4db7-9af0-08faaf7691a4	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Aurobindo Pharma Limited	2564646d-183c-4759-8726-155a4c22aa2b	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol	BISOPROLOL FUMARATE	Bryant Ranch Prepack	7ec24259-0f37-4389-873b-e62267a21d67	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Harman Finochem Limited	65da2d2e-cce8-4bf6-a12d-3565b4b6b7c8	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol Fumarate	BISOPROLOL FUMARATE	AvPAK	d540ef44-9016-9d66-e053-2a95a90a16a9	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Bisoprolol Fumarate generic name: BISOPROLOL FUMARATE
Bisoprolol	BISOPROLOL FUMARATE	Bryant Ranch Prepack	78056d0b-2265-4da3-a4fe-b96d98289848	2023-12-07	Warnings, Adverse reactions	Name fallback generic name: BISOPROLOL FUMARATE
Bisoprolol	BISOPROLOL FUMARATE	Bryant Ranch Prepack	91d114ce-5551-455e-82df-d058eb222ac1	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: BISOPROLOL FUMARATE
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

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