Application 203659

Type: ANDA
Sponsor: AMERIGEN PHARMS LTD

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
A203659-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16
A203659-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16
A203659-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16
A203659-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203659-001	AB
A203659-002	AB
A203659-003	AB
A203659-004	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 5 · 164 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	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203659-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203659-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203659-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203659-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-04-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 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	A203659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203659-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203659-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203659-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203659-004	AB	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A203659-001	PC	2021-12-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203659-002	PC	2021-12-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203659-003	PC	2021-12-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203659-004	PC	2021-12-17	`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
Nebivolol	NEBIVOLOL	Golden State Medical Supply, Inc.	c9d8edb5-5312-ad38-e053-2995a90a7154	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203659 application number: ANDA203659 ndc (product): 51407-485 ndc (product): 51407-483 ndc (product): 51407-486 ndc (product): 51407-484
Nebivolol	NEBIVOLOL	ANI Pharmaceuticals, Inc.	3ebcc539-efe0-4545-bd83-37c20de7efb0	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203659 application number: ANDA203659 ndc (product): 62559-278 ndc (product): 62559-276 ndc (product): 62559-275 ndc (product): 62559-277

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43975-248	Nebivolol	Nebivolol	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-249	Nebivolol	Nebivolol	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-250	Nebivolol	Nebivolol	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-251	Nebivolol	Nebivolol	Amerigen Pharmaceuticals Inc.	ANDA	Current
51407-483	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-483	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-483	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-483	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-483	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-484	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-484	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-484	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-484	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-484	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-485	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-485	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-485	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-485	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-485	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-486	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-486	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-486	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
51407-486	Nebivolol	Nebivolol	Golden State Medical Supply, Inc.	ANDA	Current
62559-275	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-275	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-275	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-276	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-276	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-276	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-277	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-277	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-277	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-278	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-278	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-278	Nebivolol	Nebivolol	ANI Pharmaceuticals, Inc.	ANDA	Current