Application 075831

Type: ANDA
Sponsor: MYLAN

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 1.

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
A075831-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL			2005-12-14
A075831-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL			2005-12-14

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2005-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2005-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075831-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL		2005-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075831-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL		2005-12-14	`782e0a99824c…`

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	A075831-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075831-002	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A075831-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075831-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075831-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075831-002	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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisoprolol fumarate	BISOPROLOL FUMARATE	Natco Pharma USA LLC	e907bfcb-5e64-45b8-ae9d-822b3d360104	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075831 application number: ANDA075831

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0523	Bisoprolol Fumarate	bisoprolol fumarate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0523	Bisoprolol Fumarate	bisoprolol fumarate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0524	Bisoprolol Fumarate	bisoprolol fumarate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0524	Bisoprolol Fumarate	bisoprolol fumarate	Mylan Pharmaceuticals Inc.	ANDA	Current