Application 207761

Type: ANDA
Sponsor: ZYDUS PHARMS

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 42.

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
A207761-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28
A207761-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28
A207761-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207761-001	AB
A207761-002	AB
A207761-003	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 · 126 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	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207761-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207761-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207761-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-07-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A207761-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207761-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207761-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207761-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207761-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207761-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207761-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207761-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207761-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207761-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207761-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207761-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207761-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207761-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207761-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207761-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207761-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207761-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207761-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207761-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207761-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207761-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207761-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207761-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207761-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207761-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207761-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207761-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207761-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207761-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207761-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207761-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207761-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207761-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207761-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207761-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207761-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207761-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207761-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207761-001	AB	1	`1e350fbaab3a…`

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
Nadolol	NADOLOL	Zydus Lifesciences Limited	29433c5a-51c6-4fb9-9174-1b1c616c9e57	2024-12-05		Exact identifier application applno (ANDA): 207761 application number: ANDA207761 ndc (product): 70771-1091 ndc (product): 70771-1089 ndc (product): 70771-1090
Nadolol	NADOLOL	Bryant Ranch Prepack	0d66548a-231e-4104-be0c-c6ce1586b46c	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207761 application number: ANDA207761 ndc (product): 71335-0697
Nadolol	NADOLOL	Zydus Pharmaceuticals USA Inc.	a0a38f9b-268d-4463-881d-5bee6cd92e8a	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207761 application number: ANDA207761 ndc (product): 68382-734 ndc (product): 68382-733 ndc (product): 68382-732

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-732	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-732	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-732	Nadolol	Nadolol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-732	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-733	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-733	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-733	Nadolol	Nadolol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-733	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-734	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-734	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-734	Nadolol	Nadolol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-734	Nadolol	Nadolol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-2139	Nadolol	Nadolol	REMEDYREPACK INC.	ANDA	Current
70518-2139	Nadolol	Nadolol	REMEDYREPACK INC.	ANDA	Current
70518-2139	Nadolol	Nadolol	REMEDYREPACK INC.	ANDA	Current
70771-1089	Nadolol	Nadolol	Zydus Lifesciences Limited	ANDA	Current
70771-1089	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1089	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1089	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1090	Nadolol	Nadolol	Zydus Lifesciences Limited	ANDA	Current
70771-1090	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1090	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1090	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1091	Nadolol	Nadolol	Zydus Lifesciences Limited	ANDA	Current
70771-1091	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1091	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
70771-1091	Nadolol	Nadolol	Cadila Healthcare Limited	ANDA	Current
71335-0697	Nadolol	Nadolol	Bryant Ranch Prepack	ANDA	Current
71335-0697	Nadolol	Nadolol	Bryant Ranch Prepack	ANDA	Current
71335-0697	Nadolol	Nadolol	Bryant Ranch Prepack	ANDA	Current
71335-0697	Nadolol	Nadolol	Bryant Ranch Prepack	ANDA	Current