Application 204891

Type: ANDA
Sponsor: ORIT LABS LLC

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
A204891-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2017-01-11
A204891-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB		2017-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204891-001	AB
A204891-002	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 · 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	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204891-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2017-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204891-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2017-01-11	`782e0a99824c…`

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	A204891-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204891-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204891-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204891-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204891-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204891-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204891-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204891-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204891-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204891-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204891-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204891-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204891-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204891-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204891-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204891-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204891-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204891-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204891-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204891-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204891-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204891-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204891-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204891-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204891-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204891-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204891-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204891-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204891-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Limited	ae10b8e1-557d-4437-8a1d-89d7844122c8	2023-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204891 application number: ANDA204891
BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	9b2eb4ea-001e-436c-93ba-20a7f5bc5f04	2021-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204891 application number: ANDA204891 ndc (product): 62332-604 ndc (product): 62332-603

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
15955-373	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	ORIT LABORATORIES LLC	ANDA	Current
15955-373	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Labs LLC	ANDA	Current
15955-374	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	ORIT LABORATORIES LLC	ANDA	Current
15955-374	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Labs LLC	ANDA	Current
62332-603	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-603	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-604	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-604	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	Alembic Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46880	ORIG	2017-01-18