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Details for New Drug Application (NDA): 065323

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NDA 065323 describes CEFUROXIME AXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Sun Pharm Inds Ltd, Sandoz, Lupin, Ranbaxy Labs Ltd, Orchid Hlthcare, Wockhardt, Apotex, Ani Pharms Inc, and Alkem Labs Ltd, and is included in eleven NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for NDA: 065323

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065323


Suppliers and Packaging for NDA: 065323

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefuroxime axetil
FOR SUSPENSION;ORAL 065323 ANDA Ranbaxy Pharmaceuticals Inc 63304-963 63304-963-03 50 mL in 1 BOTTLE (63304-963-03)
cefuroxime axetil
FOR SUSPENSION;ORAL 065323 ANDA Ranbaxy Pharmaceuticals Inc 63304-963 63304-963-04 100 mL in 1 BOTTLE (63304-963-04)

Summary for product number 001

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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.