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Last Updated: November 24, 2024

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, Anda Repository, Ani Pharms, Apotex, Aurobindo Pharma, Chartwell Rx, Fosun Pharma, Lupin, and Ranbaxy Labs Ltd, and is included in eleven NDAs. It is available from fifteen suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.

The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Fifteen 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

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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