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Generated: May 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065409

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NDA 065409 describes CEFPODOXIME PROXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Sandoz, Aurobindo Pharma, Sun Pharm Inds Ltd, and Orchid Hlthcare, and is included in seven NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.

Summary for NDA: 065409

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065409


Suppliers and Packaging for NDA: 065409

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefpodoxime proxetil
FOR SUSPENSION;ORAL 065409 ANDA NorthStar Rx LLC 16714-402 16714-402-01 1 BOTTLE in 1 CARTON (16714-402-01) > 50 mL in 1 BOTTLE
cefpodoxime proxetil
FOR SUSPENSION;ORAL 065409 ANDA NorthStar Rx LLC 16714-402 16714-402-02 1 BOTTLE in 1 CARTON (16714-402-02) > 100 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 50MG BASE/5ML
Approval Date:Jun 8, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Jun 8, 2007TE:ABRLD:No

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