Application 074172

Type: ANDA
Sponsor: MYLAN

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
A074172-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31
A074172-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31
A074172-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074172-001	AB
A074172-002	AB
A074172-003	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	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074172-002	NADOLOL	40MG	TABLET / ORAL	AB	1993-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074172-003	NADOLOL	80MG	TABLET / ORAL	AB	1993-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074172-001	NADOLOL	20MG	TABLET / ORAL	AB	1993-10-31	`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	A074172-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074172-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074172-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074172-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074172-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074172-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074172-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074172-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074172-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074172-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074172-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074172-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074172-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074172-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074172-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074172-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074172-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074172-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074172-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074172-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074172-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074172-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074172-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074172-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074172-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074172-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074172-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074172-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074172-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074172-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074172-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074172-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074172-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074172-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074172-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074172-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074172-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074172-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074172-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074172-001	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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nadolol	NADOLOL	American Health Packaging	9acc0c81-4145-43cc-b31a-7b1e3313259d	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	A-S Medication Solutions	4580b85b-437c-4c52-bf31-5976968ecd5c	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	c154d99c-e4fb-41d0-8fac-e1982672e8d7	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	BluePoint Laboratories	f11553f1-18ec-41b0-a7ad-1c9f21ef2c9f	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	REMEDYREPACK INC.	8a224f90-24a5-411e-ac26-6496a1930f3a	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Amneal Pharmaceuticals NY LLC	e2e24b14-0169-4028-828a-894ad3c2ba55	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
NADOLOL	NADOLOL	Bryant Ranch Prepack	64a788d0-b7f0-4f39-8adb-ab68870ecfa5	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: NADOLOL generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	2d126308-c58d-4950-9dcb-eaadb1a2054f	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Golden State Medical Supply, Inc.	33dcfdb9-1741-71e1-e063-6294a90afdff	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	UNICHEM PHARMACEUTICALS (USA), INC.	5a8014fb-9b65-4457-bfd5-0ab7e6de330e	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	American Health Packaging	9e8e129d-cb17-45fc-b3e2-2600c0166463	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	BluePoint Laboratories	15822faf-6924-4a63-a4e1-6058b308708c	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Zydus Lifesciences Limited	29433c5a-51c6-4fb9-9174-1b1c616c9e57	2024-12-05		Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	0d66548a-231e-4104-be0c-c6ce1586b46c	2024-10-02	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	BluePoint Laboratories	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	2024-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	2fc1f850-9653-4082-929a-926b644810e7	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	9cf4ca73-2d38-44c2-a522-d44d536b5e55	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
Nadolol	NADOLOL	Aurobindo Pharma Limited	44c5352d-89f8-4bd3-9479-1069304562ca	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL
NADOLOL	NADOLOL	Alembic Pharmaceuticals Inc.	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: NADOLOL generic name: NADOLOL
Nadolol	NADOLOL	Zydus Pharmaceuticals USA Inc.	a0a38f9b-268d-4463-881d-5bee6cd92e8a	2024-01-02	Warnings, Adverse reactions	Name fallback brand name: Nadolol generic name: NADOLOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0028	Nadolol	nadolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0028	Nadolol	nadolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1132	Nadolol	nadolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1132	Nadolol	nadolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1171	Nadolol	nadolol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1171	Nadolol	nadolol	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-812	Nadolol	nadolol	Mylan Institutional Inc.	ANDA	Current
51079-812	Nadolol	nadolol	Mylan Institutional Inc.	ANDA	Current
51079-813	Nadolol	nadolol	Mylan Institutional Inc.	ANDA	Current
51079-813	Nadolol	nadolol	Mylan Institutional Inc.	ANDA	Current
63629-6942	Nadolol	nadolol	Bryant Ranch Prepack	ANDA	Current
63629-6942	Nadolol	nadolol	Bryant Ranch Prepack	ANDA	Current