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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 062698

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NDA 062698 describes CEFADROXIL, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Ani Pharms, Apothecon, Aurobindo, Hikma Pharms, Sun Pharm Inds Ltd, and Ranbaxy, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the CEFADROXIL profile page.

The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Nineteen suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.

Summary for 062698

Tradename:	CEFADROXIL
Applicant:	Ani Pharms
Ingredient:	cefadroxil/cefadroxil hemihydrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Mar 1, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 250MG BASE/5ML
Approval Date:	Mar 1, 1989	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 500MG BASE/5ML
Approval Date:	Mar 1, 1989	TE:		RLD:	No

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