Application 018063

Type: NDA
Sponsor: US WORLDMEDS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORGARD	NADOLOL	TABLET;ORAL	40MG	Yes	No
002	CORGARD	NADOLOL	TABLET;ORAL	80MG	Yes	Yes
003	CORGARD	NADOLOL	TABLET;ORAL	120MG	No	No
004	CORGARD	NADOLOL	TABLET;ORAL	160MG	No	No
005	CORGARD	NADOLOL	TABLET;ORAL	20MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018063-001	CORGARD	NADOLOL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N018063-002	CORGARD	NADOLOL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N018063-003	CORGARD	NADOLOL	120MG	TABLET / ORAL	Approved before 1982
N018063-004	CORGARD	NADOLOL	160MG	TABLET / ORAL	Approved before 1982
N018063-005	CORGARD	NADOLOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-10-28

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 2 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018063-001	CORGARD	40MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018063-002	CORGARD	80MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018063-005	CORGARD	20MG	TABLET / ORAL		RLD	1986-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018063-001	CORGARD	40MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018063-002	CORGARD	80MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018063-005	CORGARD	20MG	TABLET / ORAL		RLD	1986-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018063-001	CORGARD	40MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018063-002	CORGARD	80MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018063-005	CORGARD	20MG	TABLET / ORAL		RLD	1986-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018063-001	CORGARD	40MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018063-002	CORGARD	80MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018063-005	CORGARD	20MG	TABLET / ORAL		RLD	1986-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018063-001	CORGARD	40MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018063-002	CORGARD	80MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018063-005	CORGARD	20MG	TABLET / ORAL		RLD	1986-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-001	CORGARD	40MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-002	CORGARD	80MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-005	CORGARD	20MG	TABLET / ORAL	AB	RLD	1986-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-001	CORGARD	40MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-002	CORGARD	80MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-005	CORGARD	20MG	TABLET / ORAL	AB	RLD	1986-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-001	CORGARD	40MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-002	CORGARD	80MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-003	CORGARD	120MG	TABLET / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-004	CORGARD	160MG	TABLET / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-005	CORGARD	20MG	TABLET / ORAL	AB	RLD	1986-10-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018063-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018063-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018063-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018063-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018063-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018063-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018063-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018063-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018063-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018063-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018063-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018063-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018063-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018063-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018063-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018063-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018063-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018063-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018063-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018063-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018063-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018063-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018063-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018063-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018063-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018063-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018063-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018063-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018063-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018063-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018063-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018063-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018063-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018063-001	AB	1	`c0c555d07b60…`

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	BluePoint Laboratories	f11553f1-18ec-41b0-a7ad-1c9f21ef2c9f	2026-09-07	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	American Health Packaging	9acc0c81-4145-43cc-b31a-7b1e3313259d	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	A-S Medication Solutions	4580b85b-437c-4c52-bf31-5976968ecd5c	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	c154d99c-e4fb-41d0-8fac-e1982672e8d7	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	REMEDYREPACK INC.	8a224f90-24a5-411e-ac26-6496a1930f3a	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Amneal Pharmaceuticals NY LLC	e2e24b14-0169-4028-828a-894ad3c2ba55	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
NADOLOL	NADOLOL	Bryant Ranch Prepack	64a788d0-b7f0-4f39-8adb-ab68870ecfa5	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	2d126308-c58d-4950-9dcb-eaadb1a2054f	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback 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 generic name: NADOLOL
Nadolol	NADOLOL	UNICHEM PHARMACEUTICALS (USA), INC.	5a8014fb-9b65-4457-bfd5-0ab7e6de330e	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	American Health Packaging	9e8e129d-cb17-45fc-b3e2-2600c0166463	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	BluePoint Laboratories	15822faf-6924-4a63-a4e1-6058b308708c	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Zydus Lifesciences Limited	29433c5a-51c6-4fb9-9174-1b1c616c9e57	2024-12-05		Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	0d66548a-231e-4104-be0c-c6ce1586b46c	2024-10-02	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	BluePoint Laboratories	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	2024-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	2fc1f850-9653-4082-929a-926b644810e7	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Bryant Ranch Prepack	9cf4ca73-2d38-44c2-a522-d44d536b5e55	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Aurobindo Pharma Limited	44c5352d-89f8-4bd3-9479-1069304562ca	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
NADOLOL	NADOLOL	Alembic Pharmaceuticals Inc.	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	2024-01-08	Warnings, Adverse reactions	Name fallback generic name: NADOLOL
Nadolol	NADOLOL	Zydus Pharmaceuticals USA Inc.	a0a38f9b-268d-4463-881d-5bee6cd92e8a	2024-01-02	Warnings, Adverse reactions	Name fallback 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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27505-100	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-100	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-100	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-100	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-100	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-101	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-101	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-101	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-101	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-101	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-102	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-102	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-102	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-102	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
27505-102	Corgard	nadolol	US WorldMeds, LLC	NDA	Current
59762-0810	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0810	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0810	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0810	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0811	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0811	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0811	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0811	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0812	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0812	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0812	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0812	Nadolol	nadolol	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
78670-100	Corgard	nadolol	USWM, LLC	NDA	Current
78670-100	Corgard	nadolol	USWM, LLC	NDA	Current
78670-101	Corgard	nadolol	USWM, LLC	NDA	Current
78670-101	Corgard	nadolol	USWM, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77156	SUPPL	2023-12-27
77129	SUPPL	2023-12-27
14006	SUPPL	2013-07-16
33409	SUPPL	2013-07-15
33408	SUPPL	2011-06-27
818	SUPPL	2011-06-07
11139	SUPPL	2008-02-14
14005	SUPPL	2008-02-07