Last Updated: July 18, 2026

Details for New Drug Application (NDA): 062713

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NDA 062713 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-two NDAs. It is available from thirty-eight 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-eight suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

Summary for 062713

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

Medical Subject Heading (MeSH) Categories for 062713

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Jul 15, 1988	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Jul 15, 1988	TE:	AB	RLD:	No

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