Details for New Drug Application (NDA): 211763

NDA 211763 describes NADOLOL, which is a drug marketed by Alembic, Amneal Pharms Co, Aurobindo Pharma, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Rising, Rk Pharma, Sandoz, Teva Pharms, Zydus Pharms, Impax Labs, and Natco Pharma, and is included in sixteen NDAs. It is available from sixteen 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 211763

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

Pharmacology for NDA: 211763

Mechanism of Action

Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 211763

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Sympatholytics

Suppliers and Packaging for NDA: 211763

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NADOLOL	nadolol	TABLET;ORAL	211763	ANDA	Alembic Pharmaceuticals Limited	46708-402	46708-402-30	30 TABLET in 1 BOTTLE (46708-402-30)
NADOLOL	nadolol	TABLET;ORAL	211763	ANDA	Alembic Pharmaceuticals Limited	46708-402	46708-402-31	100 TABLET in 1 BOTTLE (46708-402-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 2, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jun 2, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jun 2, 2023	TE:	AB	RLD:	No

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