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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 090031

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NDA 090031 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 090031

Tradename:	CEFPODOXIME PROXETIL
Applicant:	Chartwell Rx
Ingredient:	cefpodoxime proxetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 50MG BASE/5ML
Approval Date:	Jan 14, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 100MG BASE/5ML
Approval Date:	Jan 14, 2009	TE:		RLD:	No

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