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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 218947

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NDA 218947 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-four 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-four suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

Summary for 218947

Tradename:	CEPHALEXIN
Applicant:	Alkem Labs Ltd
Ingredient:	cephalexin
Patents:	0

Pharmacology for NDA: 218947

Medical Subject Heading (MeSH) Categories for 218947

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 218947

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEPHALEXIN	cephalexin	TABLET;ORAL	218947	ANDA	Ascend Laboratories, LLC	67877-891	67877-891-01	100 TABLET in 1 BOTTLE (67877-891-01)
CEPHALEXIN	cephalexin	TABLET;ORAL	218947	ANDA	Ascend Laboratories, LLC	67877-892	67877-892-01	100 TABLET in 1 BOTTLE (67877-892-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Sep 27, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Sep 27, 2024	TE:	AB	RLD:	No

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