Last Updated: May 2, 2026

Details for New Drug Application (NDA): 065444

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NDA 065444 describes CEPHALEXIN, which is a drug marketed by Ajenat Pharms, Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Chartwell Rx, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Hikma Pharms, Vitarine, Yung Shin Pharm, and Aurobindo Pharma Ltd, and is included in fifty-one NDAs. It is available from thirty-seven suppliers. Additional details are available on the CEPHALEXIN profile page.

The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

Summary for 065444

Tradename:	CEPHALEXIN
Applicant:	Hikma Pharms
Ingredient:	cephalexin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065444

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Aug 28, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 250MG BASE/5ML
Approval Date:	Aug 28, 2009	TE:		RLD:	No

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