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Last Updated: November 22, 2024

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, Chartwell Rx, Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, and Sandoz, and is included in eight NDAs. It is available from ten 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. Ten suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.
Summary for 065409
Tradename:CEFPODOXIME PROXETIL
Applicant:Aurobindo Pharma Ltd
Ingredient:cefpodoxime proxetil
Patents:0
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 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 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

Profile for product number 001

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

Profile for product number 002

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

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