Application 208832

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NADOLOL	NADOLOL	TABLET;ORAL	20MG	No	No
002	NADOLOL	NADOLOL	TABLET;ORAL	40MG	No	No
003	NADOLOL	NADOLOL	TABLET;ORAL	80MG	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
A208832-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02
A208832-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02
A208832-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208832-001	AB
A208832-002	AB
A208832-003	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 4 · 123 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	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A208832-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208832-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208832-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208832-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208832-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208832-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208832-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nadolol	NADOLOL	A-S Medication Solutions	4580b85b-437c-4c52-bf31-5976968ecd5c	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208832 application number: ANDA208832
Nadolol	NADOLOL	Amneal Pharmaceuticals NY LLC	e2e24b14-0169-4028-828a-894ad3c2ba55	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208832 application number: ANDA208832 ndc (product): 69238-1123 ndc (product): 69238-1124 ndc (product): 69238-1125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1123	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1123	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1123	Nadolol	Nadolol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1123	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1123	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1124	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1124	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1124	Nadolol	Nadolol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1124	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1124	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1125	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1125	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1125	Nadolol	Nadolol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1125	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1125	Nadolol	Nadolol	Amneal Pharmaceuticals NY LLC	ANDA	Current