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US Army
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Federal Trade Commission
Deloitte
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Chubb
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074501

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NDA 074501 describes NADOLOL, which is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Invagen Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan, Sandoz, Teva Pharms, Zydus Pharms Usa Inc, and Impax Labs, and is included in twelve 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. Two suppliers are listed for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
Summary for 074501
Tradename:NADOLOL
Applicant:Sandoz
Ingredient:nadolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074501
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 074501
Suppliers and Packaging for NDA: 074501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NADOLOL nadolol TABLET;ORAL 074501 ANDA Sandoz Inc 0781-1181 N 0781-1181-01
NADOLOL nadolol TABLET;ORAL 074501 ANDA Sandoz Inc 0781-1181 N 0781-1181-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 9, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 9, 1995TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 9, 1995TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Chinese Patent Office
Argus Health
Cantor Fitzgerald
Cipla
Farmers Insurance
McKinsey
Covington
Mallinckrodt

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