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Last Updated: November 28, 2023

Details for New Drug Application (NDA): 018063

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NDA 018063 describes CORGARD, which is a drug marketed by Uswm and is included in one NDA. It is available from one supplier. Additional details are available on the CORGARD profile page.

The generic ingredient in CORGARD is nadolol. There are five drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the nadolol profile page.

Summary for 018063

Tradename:	CORGARD
Applicant:	Uswm
Ingredient:	nadolol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018063

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 018063

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics

Suppliers and Packaging for NDA: 018063

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CORGARD	nadolol	TABLET;ORAL	018063	NDA	USWM, LLC	78670-100	78670-100-01	100 TABLET in 1 BOTTLE (78670-100-01)
CORGARD	nadolol	TABLET;ORAL	018063	NDA	USWM, LLC	78670-101	78670-101-01	100 TABLET in 1 BOTTLE (78670-101-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	120MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 018063

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-005	Oct 28, 1986	⤷ Try a Trial	⤷ Try a Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-004	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Uswm	CORGARD	nadolol	TABLET;ORAL	018063-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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