Details for New Drug Application (NDA): 212856

NDA 212856 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 fifteen 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 212856

Tradename:	NADOLOL
Applicant:	Rk Pharma
Ingredient:	nadolol
Patents:	0

Pharmacology for NDA: 212856

Mechanism of Action

Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 212856

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Sympatholytics

Suppliers and Packaging for NDA: 212856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NADOLOL	nadolol	TABLET;ORAL	212856	ANDA	VGYAAN Pharmaceuticals LLC	72664-211	72664-211-01	100 TABLET in 1 BOTTLE, PLASTIC (72664-211-01)
NADOLOL	nadolol	TABLET;ORAL	212856	ANDA	VGYAAN Pharmaceuticals LLC	72664-212	72664-212-01	100 TABLET in 1 BOTTLE, PLASTIC (72664-212-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 13, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Sep 13, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Sep 13, 2019	TE:	AB	RLD:	No

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