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Last Updated: January 30, 2026

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 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 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:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 50MG BASE/5ML
Approval Date:	Jun 8, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 100MG BASE/5ML
Approval Date:	Jun 8, 2007	TE:		RLD:	No

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