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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203455

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NDA 203455 describes NADOLOL, which is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Invagen Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan, Riconpharma Llc, Sandoz, Teva Pharms, Zydus Pharms Usa Inc, and Impax Labs, and is included in thirteen 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 203455
Tradename:NADOLOL
Applicant:Invagen Pharms
Ingredient:nadolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203455
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 203455
Suppliers and Packaging for NDA: 203455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NADOLOL nadolol TABLET;ORAL 203455 ANDA Camber, Pharmaceuticals Inc 31722-347 E 31722-347-01
NADOLOL nadolol TABLET;ORAL 203455 ANDA Camber, Pharmaceuticals Inc 31722-347 E 31722-347-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 18, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 18, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Dec 18, 2015TE:ABRLD:No

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