Application 215563

Type: ANDA
Sponsor: NOVITIUM PHARMA

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
A215563-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2021-10-29
A215563-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB		2021-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215563-001	AB
A215563-002	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 2 · 66 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	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215563-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB	2021-10-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215563-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	2021-10-29	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A215563-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215563-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215563-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215563-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215563-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215563-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215563-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215563-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215563-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215563-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215563-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215563-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215563-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215563-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215563-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215563-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215563-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215563-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215563-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215563-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215563-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215563-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215563-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215563-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215563-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215563-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215563-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215563-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215563-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215563-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215563-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215563-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215563-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215563-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215563-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215563-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215563-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215563-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215563-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215563-002	AB	1	`6a51e52b5d6a…`

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	Golden State Medical Supply, Inc.	df37d337-9978-0c31-e053-2a95a90a3258	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215563 application number: ANDA215563 ndc (product): 51407-645 ndc (product): 51407-646
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	f6ce8f14-43fc-4c5e-8378-62ca7121e918	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215563 application number: ANDA215563 ndc (product): 71335-2178
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Novitium Pharma LLC	6517d564-ea55-4084-a8ab-34fea548c24e	2021-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215563 application number: ANDA215563 ndc (product): 70954-455 ndc (product): 70954-456

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
51407-645	Bisoprolol Fumarate	Bisoprolol Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-646	Bisoprolol Fumarate	Bisoprolol Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
70954-455	Bisoprolol Fumarate	Bisoprolol Fumarate	Novitium Pharma LLC	ANDA	Current
70954-456	Bisoprolol Fumarate	Bisoprolol Fumarate	Novitium Pharma LLC	ANDA	Current
71335-2178	Bisoprolol Fumarate	Bisoprolol Fumarate	Bryant Ranch Prepack	ANDA	Current