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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065462

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NDA 065462 describes CEFPODOXIME PROXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Sandoz, Sun Pharm Inds Ltd, Aurobindo Pharma, and Orchid Hlthcare, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the CEFPODOXIME PROXETIL profile page.

The generic ingredient in CEFPODOXIME PROXETIL is cefpodoxime proxetil. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.
Summary for 065462
Tradename:CEFPODOXIME PROXETIL
Applicant:Sandoz
Ingredient:cefpodoxime proxetil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065462
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFPODOXIME PROXETIL cefpodoxime proxetil TABLET;ORAL 065462 ANDA Sandoz Inc 0781-5438 N 0781-5438-01
CEFPODOXIME PROXETIL cefpodoxime proxetil TABLET;ORAL 065462 ANDA Sandoz Inc 0781-5438 N 0781-5438-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:May 28, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:May 28, 2008TE:ABRLD:No

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