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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065308

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NDA 065308 describes CEFUROXIME AXETIL, which is a drug marketed by Sun Pharm Inds Ltd, Alkem Labs Ltd, Ani Pharms Inc, Apotex, Aurobindo Pharma Ltd, Fosun Pharma, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, and Wockhardt, and is included in eleven NDAs. It is available from twenty suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.

The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
Summary for 065308
Tradename:CEFUROXIME AXETIL
Applicant:Aurobindo Pharma Ltd
Ingredient:cefuroxime axetil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065308
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065308 ANDA NorthStar Rx LLC 16714-400 N 16714-400-02
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065308 ANDA NorthStar Rx LLC 16714-400 N 16714-400-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 125MG BASE
Approval Date:Mar 29, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Mar 29, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Mar 29, 2006TE:ABRLD:No

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