Application 215562

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	2.5MG;6.25MG	No	No
002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	5MG;6.25MG	No	No
003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;6.25MG	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
A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04
A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04
A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215562-001	AB
A215562-002	AB
A215562-003	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 · 99 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	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215562-002	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215562-003	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	10MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215562-001	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG	TABLET / ORAL	AB	2021-11-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A215562-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215562-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215562-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215562-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215562-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215562-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215562-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215562-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215562-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215562-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215562-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215562-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215562-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215562-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215562-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215562-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215562-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215562-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215562-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215562-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215562-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215562-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215562-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215562-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215562-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215562-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215562-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215562-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215562-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215562-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215562-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215562-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215562-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215562-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215562-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215562-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215562-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215562-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215562-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215562-001	AB	1	`8072bd15b7f6…`

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 and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	90bb2207-2eaf-495b-a222-c69d4db9e7a3	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215562 application number: ANDA215562
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Marlex Pharmaceuticals, Inc.	df881501-42ae-624a-e053-2995a90ab2a0	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215562 application number: ANDA215562 ndc (product): 10135-740 ndc (product): 10135-741 ndc (product): 10135-742
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c	2024-03-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215562 application number: ANDA215562 ndc (product): 70954-412 ndc (product): 70954-414 ndc (product): 70954-413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-740	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-741	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-742	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Marlex Pharmaceuticals, Inc.	ANDA	Current
70954-412	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Novitium Pharma LLC	ANDA	Current
70954-412	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Novitium Pharma LLC	ANDA	Current
70954-413	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Novitium Pharma LLC	ANDA	Current
70954-413	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Novitium Pharma LLC	ANDA	Current
70954-414	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Novitium Pharma LLC	ANDA	Current
70954-414	Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	Novitium Pharma LLC	ANDA	Current