Application 075643

Type: ANDA
Sponsor: CASI PHARMS INC

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
003	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A075643-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16
A075643-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16
A075643-003	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075643-001	AB
A075643-002	AB

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
2026-02-19 14:30 UTC	2026-02	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075643-003	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-003	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075643-003	BISOPROLOL FUMARATE	2.5MG	TABLET / ORAL		2025-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075643-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2000-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075643-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2000-11-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075643-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075643-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075643-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075643-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075643-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075643-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075643-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075643-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075643-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075643-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075643-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075643-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075643-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075643-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075643-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075643-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075643-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075643-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075643-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075643-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075643-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075643-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075643-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075643-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075643-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075643-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075643-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075643-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075643-002	AB	1	`782e0a99824c…`

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 · 3 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	6ebe6ec0-6223-425c-9f3b-8ab8dd8b3f5f	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075643 application number: ANDA075643
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Advagen Pharma Ltd	83e4b4e5-9130-44c8-abab-fcd0db5d8c49	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075643 application number: ANDA075643 ndc (product): 72888-092 ndc (product): 72888-093
Bisoprolol Fumarate	BISOPROLOL FUMARATE	TruPharma LLC	0ef9e45c-21ee-4e00-a9b8-280e2035b4d3	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075643 application number: ANDA075643

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0771	bisoprolol fumarate	bisoprolol fumarate	Eon Labs, Inc.	ANDA	Current
0185-0774	bisoprolol fumarate	bisoprolol fumarate	Eon Labs, Inc.	ANDA	Current
68084-487	bisoprolol fumarate	bisoprolol fumarate	American Health Packaging	ANDA	Current
72888-092	Bisoprolol Fumarate	Bisoprolol Fumarate	Advagen Pharma Ltd	ANDA	Current
72888-093	Bisoprolol Fumarate	Bisoprolol Fumarate	Advagen Pharma Ltd	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30972	ORIG	2000-11-16