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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065166

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NDA 065166 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-nine 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. Thirty suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
Summary for 065166
Tradename:CEFUROXIME AXETIL
Applicant:Wockhardt
Ingredient:cefuroxime axetil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065166
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065166 ANDA PD-Rx Pharmaceuticals, Inc. 43063-269 N 43063-269-04
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065166 ANDA PD-Rx Pharmaceuticals, Inc. 43063-307 N 43063-307-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 125MG BASE
Approval Date:Jul 29, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jul 29, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jul 29, 2005TE:ABRLD:No

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