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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 063024

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NDA 063024 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-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 063024

Tradename:	CEPHALEXIN
Applicant:	Teva
Ingredient:	cephalexin
Patents:	0

Pharmacology for NDA: 063024

Medical Subject Heading (MeSH) Categories for 063024

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 063024

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEPHALEXIN	cephalexin	TABLET;ORAL	063024	ANDA	Teva Pharmaceuticals USA, Inc.	0093-2238	0093-2238-01	100 TABLET in 1 BOTTLE (0093-2238-01)
CEPHALEXIN	cephalexin	TABLET;ORAL	063024	ANDA	Teva Pharmaceuticals USA, Inc.	0093-2240	0093-2240-01	100 TABLET in 1 BOTTLE (0093-2240-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Jan 12, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Jan 12, 1989	TE:		RLD:	No

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