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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065370

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NDA 065370 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 065370
Applicant:Aurobindo Pharma
Ingredient:cefpodoxime proxetil
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065370
Suppliers and Packaging for NDA: 065370
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFPODOXIME PROXETIL cefpodoxime proxetil TABLET;ORAL 065370 ANDA NorthStar Rx LLC 16714-394 N 16714-394-01
CEFPODOXIME PROXETIL cefpodoxime proxetil TABLET;ORAL 065370 ANDA NorthStar Rx LLC 16714-395 N 16714-395-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 11, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jun 11, 2007TE:ABRLD:No

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