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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 065350

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NDA 065350 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 065350

Tradename:	CEFACLOR
Applicant:	Hikma
Ingredient:	cefaclor
Patents:	0

Medical Subject Heading (MeSH) Categories for 065350

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Apr 3, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Apr 3, 2007	TE:		RLD:	No

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