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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Farmers Insurance
US Army
Harvard Business School
Dow
UBS
Johnson and Johnson
Medtronic
Merck

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065323

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NDA 065323 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 065323
Tradename:CEFUROXIME AXETIL
Applicant:Sun Pharm Inds Ltd
Ingredient:cefuroxime axetil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065323
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065323
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME AXETIL cefuroxime axetil FOR SUSPENSION;ORAL 065323 ANDA Ranbaxy Pharmaceuticals Inc 63304-963 E 63304-963-03
CEFUROXIME AXETIL cefuroxime axetil FOR SUSPENSION;ORAL 065323 ANDA Ranbaxy Pharmaceuticals Inc 63304-963 E 63304-963-04

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Feb 5, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Feb 5, 2008TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Merck
US Department of Justice
Julphar
UBS
Baxter
Cantor Fitzgerald
Citi
Queensland Health

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