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Last Updated: September 26, 2020

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, Beximco Pharms Usa, Heritage Pharma, Invagen Pharms, Lupin Ltd, Mylan, Novast Labs, Sandoz, Teva Pharms, Vgyaan, Zydus Pharms, and Impax Labs, and is included in fifteen 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 074501
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 0781-8004 0781-8004-01 100 TABLET in 1 BOTTLE (0781-8004-01)
NADOLOL nadolol TABLET;ORAL 074501 ANDA Sandoz Inc 0781-8004 0781-8004-10 1000 TABLET in 1 BOTTLE (0781-8004-10)

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 leading biopharmaceutical companies globally:

Johnson and Johnson
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