Application 074501

Type: ANDA
Sponsor: SANDOZ

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 43.

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
A074501-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09
A074501-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09
A074501-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074501-001	AB
A074501-002	AB
A074501-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074501-002	NADOLOL	40MG	TABLET / ORAL	AB	1995-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074501-003	NADOLOL	80MG	TABLET / ORAL	AB	1995-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074501-001	NADOLOL	20MG	TABLET / ORAL	AB	1995-11-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074501-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074501-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074501-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074501-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074501-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074501-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074501-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074501-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074501-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074501-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074501-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074501-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074501-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074501-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074501-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074501-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074501-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074501-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074501-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074501-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074501-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074501-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074501-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074501-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074501-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074501-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074501-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074501-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074501-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074501-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074501-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074501-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074501-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074501-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074501-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074501-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074501-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074501-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074501-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074501-001	AB	1	`301d65b070ca…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nadolol	NADOLOL	Exelan Pharmaceuticals Inc.	5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Cipla USA Inc.	c899eedb-4113-45da-acc3-8e181250a7d8	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
NADOLOL	NADOLOL	VGYAAN Pharmaceuticals LLC	85b4b931-51c4-4326-88ea-708dde8323d4	2023-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NADOLOL generic name: NADOLOL
NADOLOL	NADOLOL	Alembic Pharmaceuticals Limited	0bd202e3-c673-4945-b828-1a5bc6a896ae	2023-06-08	Warnings, Adverse reactions	Name fallback brand name: NADOLOL generic name: NADOLOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1181	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-1181	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-1182	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-1182	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-1183	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-1183	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8004	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8004	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8004	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8005	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8005	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8005	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8006	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8006	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
0781-8006	Nadolol	Nadolol	Sandoz Inc	ANDA	Current
21695-799	Nadolol	Nadolol	Rebel Distributors Corp	ANDA	Current
21695-800	Nadolol	Nadolol	Rebel Distributors Corp	ANDA	Current
21695-802	Nadolol	Nadolol	Rebel Distributors Corp	ANDA	Current
63629-7483	Nadolol	Nadolol	Bryant Ranch Prepack	ANDA	Current
68258-6034	Nadolol	Nadolol	Dispensing Solutions, Inc.	ANDA	Current