Application 203825

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 2.5MG BASE	No	No
002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No
003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No
004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203825-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03
A203825-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03
A203825-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03
A203825-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203825-001	AB
A203825-002	AB
A203825-003	AB
A203825-004	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 4 · 144 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	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A203825-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203825-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203825-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203825-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203825-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203825-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203825-004	AB	1	`d06236e962d9…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e0489	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	90d4ea48-7831-4cb0-8796-1ed79407c363	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825
Nebivolol	NEBIVOLOL	Proficient Rx LP	c6606db5-3937-4e90-9870-3cbfa4ec909e	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825
Nebivolol	NEBIVOLOL	Camber Pharmaceuticals, Inc.	202d5142-6180-4d48-9a9f-1bd6992fc49b	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825 ndc (product): 31722-587 ndc (product): 31722-588 ndc (product): 31722-586 ndc (product): 31722-585

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
31722-585	Nebivolol	Nebivolol	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-586	Nebivolol	Nebivolol	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-587	Nebivolol	Nebivolol	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-588	Nebivolol	Nebivolol	Camber Pharmaceuticals, Inc.	ANDA	Current