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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 065057

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NDA 065057 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 are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefaclor profile page.

Summary for 065057

Tradename:	CEFACLOR
Applicant:	World Gen
Ingredient:	cefaclor
Patents:	0

Medical Subject Heading (MeSH) Categories for 065057

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Jan 5, 2001	TE:		RLD:	No

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