Last Updated: November 8, 2026

Details for New Drug Application (NDA): 064116

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NDA 064116 describes CEFACLOR, which is a drug marketed by Ceph Intl, Chartwell Rx, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Yung Shin Pharm, Facta Farma, Watson Labs Inc, and World Gen, and is included in twenty-nine NDAs. It is available from four suppliers. Additional details are available on the CEFACLOR profile page.

The generic ingredient in CEFACLOR is cefaclor. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the cefaclor profile page.

Summary for 064116

Tradename:	CEFACLOR
Applicant:	Dava Pharms Inc
Ingredient:	cefaclor
Patents:	0

Medical Subject Heading (MeSH) Categories for 064116

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 250MG BASE/5ML
Approval Date:	Apr 28, 1995	TE:		RLD:	No

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