Last Updated: June 9, 2026

Details for New Drug Application (NDA): 065058

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NDA 065058 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 065058

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

Pharmacology for NDA: 065058

Medical Subject Heading (MeSH) Categories for 065058

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFACLOR	cefaclor	TABLET, EXTENDED RELEASE;ORAL	065058	ANDA	Teva Pharmaceuticals USA, Inc.	0093-1087	0093-1087-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 375MG BASE
Approval Date:	Sep 4, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Sep 4, 2002	TE:		RLD:	No

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