Application 208717

Type: ANDA
Sponsor: CADILA 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 42.

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
A208717-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17
A208717-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17
A208717-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17
A208717-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208717-001	AB
A208717-002	AB
A208717-003	AB
A208717-004	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 · 132 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
2026-08-18 06:07:40	2026-07	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`

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
2026-08-18 06:07:40	2026-07	A208717-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208717-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208717-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208717-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208717-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208717-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-004	AB	1	`d8e5a09893c0…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	0ca84bf1-511d-480d-ba3d-0eef00ddad3e	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	04a64dad-6922-4737-ab46-98c185782b38	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	abb0546f-08dd-4354-8b41-d17065b52c24	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	9a5e1bd8-f2b6-42e6-972d-09418528cd63	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Modavar Pharmaceuticals LLC	19d20396-ade8-400e-94f4-69913637d051	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717 ndc (product): 72241-035 ndc (product): 72241-034 ndc (product): 72241-032 ndc (product): 72241-033
Nebivolol	NEBIVOLOL	Cadila Pharmaceuticals Limited	451cdd6e-13b4-402f-8a44-cdf5f7433a49	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717 ndc (product): 71209-061 ndc (product): 71209-060 ndc (product): 71209-059 ndc (product): 71209-058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71209-058	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-058	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-059	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-059	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-060	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-060	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-061	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
71209-061	Nebivolol	Nebivolol	Cadila Pharmaceuticals Limited	ANDA	Current
72241-032	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-032	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-033	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-033	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-034	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-034	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-035	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current
72241-035	Nebivolol	Nebivolol	Modavar Pharmaceuticals LLC	ANDA	Current