Nadolol

Overview

Nadolol is a nonselective beta adrenal receptor blocker that is used to lower blood pressure. Nonselective beta adrenal receptor blockers may no longer be first line in the treatment of hypertension as newer generations of beta adrenal receptor blockers have higher selectivity and offer better rates of adverse effects. Nadolol was granted FDA approval on 10 December 1979.

Indication

Nadolol is indicated to treat angina pectoris and hypertension. Another product formulated with bendroflumethiazide is indicated to treat hypertension.

Associated Conditions

Angina Pectoris
Atrial Fibrillation
Gastroesophageal variceal hemorrhage prophylaxis
Hypertension
Migraine
Thyrotoxicosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	2024/10/16	NCT06643221	Early Phase 1	Recruiting	University of Arizona
Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy	2024/09/19	NCT06599684	Phase 2	Recruiting	Invirsa, Inc.
Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease	2024/04/17	NCT06370039	Phase 2	Completed	Invirsa, Inc.
Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis	2022/12/05	NCT05636228	Phase 2	Completed	Invirsa, Inc.
Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease	2022/10/19	NCT05586152	Phase 1	Completed	Invirsa, Inc.
Nadolol Versus Propranolol in Children With Infantile Hemangiomas	2015/07/22	NCT02505971	Phase 3	Completed	The Hospital for Sick Children
Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow Obstruction	2013/04/05	NCT01825122	Phase 2	Completed	Invion, Inc.
Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma	2013/03/05	NCT01804218	Phase 2	UNKNOWN	Invion, Inc.
A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding	2010/04/14	NCT01103154	Phase 4	Completed	E-DA Hospital
Nadolol for Proliferating Infantile Hemangiomas	2009/11/10	NCT01010308	Phase 2	Completed	The Hospital for Sick Children

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nadolol	Bryant Ranch Prepack	72162-2233	ORAL	40 mg in 1 1	12/17/2018
Nadolol	REMEDYREPACK INC.	70518-2139	ORAL	40 mg in 1 1	1/19/2024
Nadolol	Cipla USA Inc.	69097-868	ORAL	40 mg in 1 1	3/26/2024
Nadolol	InvaGen Pharmaceuticals Inc.	67787-349	ORAL	80 mg in 1 1	8/21/2017
Nadolol	Marlex Pharmaceuticals Inc	10135-688	ORAL	80 mg in 1 1	12/4/2023
Nadolol	Bryant Ranch Prepack	71335-2131	ORAL	80 mg in 1 1	7/26/2019
Nadolol	BluePoint Laboratories	68001-318	ORAL	40 mg in 1 1	2/2/2024
Nadolol	Golden State Medical Supply, Inc.	51407-979	ORAL	80 mg in 1 1	4/28/2025
Nadolol	Bryant Ranch Prepack	72162-2234	ORAL	20 mg in 1 1	12/17/2018
Nadolol	Bayshore Pharmaceuticals LLC	76385-133	ORAL	20 mg in 1 1	7/26/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MINT-NADOLOL	mint pharmaceuticals inc	02496380	Tablet - Oral	40 MG	7/21/2020
RATIO-NADOLOL TAB 40MG	ratiopharm inc division of teva canada limited	00851663	Tablet - Oral	40 MG	12/31/1989
NADOLOL-160 TAB 160MG	PRO DOC LIMITEE	00818720	Tablet - Oral	160 MG	12/31/1989
TEVA-NADOLOL	teva canada limited	02126761	Tablet - Oral	80 MG	12/31/1994
RATIO-NADOLOL TAB 160MG	ratiopharm inc division of teva canada limited	00851698	Tablet - Oral	160 MG	12/31/1989
APO-NADOLOL	Apotex Inc	00782467	Tablet - Oral	80 MG	12/31/1988
CORGARD TAB 40MG	bristol-myers squibb canada	00607126	Tablet - Oral	40 MG	12/31/1984
MINT-NADOLOL	mint pharmaceuticals inc	02496399	Tablet - Oral	80 MG	8/19/2020
NADOLOL-40 TAB 40MG	PRO DOC LIMITEE	00828815	Tablet - Oral	40 MG	12/31/1989
TEVA-NADOLOL	teva canada limited	02126753	Tablet - Oral	40 MG	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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