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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074255

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NDA 074255 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 074255
Tradename:NADOLOL
Applicant:Ivax Sub Teva Pharms
Ingredient:nadolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074255
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 074255
Suppliers and Packaging for NDA: 074255
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NADOLOL nadolol TABLET;ORAL 074255 ANDA Teva Pharmaceuticals USA Inc 0093-4237 N 0093-4237-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 24, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength120MG
Approval Date:Jan 24, 1996TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength160MG
Approval Date:Jan 24, 1996TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Argus Health
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Daiichi Sankyo

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