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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 074501

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NDA 074501 describes NADOLOL, which is a drug marketed by Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Regcon Holdings, Rising, Rk Pharma, Sandoz, Teva Pharms, Zydus Pharms, Impax Labs, and Natco Pharma, and is included in sixteen NDAs. It is available from seventeen suppliers. Additional details are available on the NADOLOL profile page.

The generic ingredient in NADOLOL is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.

Summary for 074501

Tradename:	NADOLOL
Applicant:	Sandoz
Ingredient:	nadolol
Patents:	0

Medical Subject Heading (MeSH) Categories for 074501

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Nov 9, 1995	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Nov 9, 1995	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Nov 9, 1995	TE:	AB	RLD:	No

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