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Last Updated: December 11, 2025

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, 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 065462

Tradename:	CEFPODOXIME PROXETIL
Applicant:	Sandoz
Ingredient:	cefpodoxime proxetil
Patents:	0

Pharmacology for NDA: 065462

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	0781-5438-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5438-01)
CEFPODOXIME PROXETIL	cefpodoxime proxetil	TABLET;ORAL	065462	ANDA	Sandoz Inc	0781-5438	0781-5438-20	20 TABLET, FILM COATED in 1 BOTTLE (0781-5438-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	May 28, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	May 28, 2008	TE:	AB	RLD:	No

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