Details for New Drug Application (NDA): 062713

NDA 062713 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Belcher Pharms, 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:	Belcher Pharms
Ingredient:	cephalexin
Patents:	0

Pharmacology for NDA: 062713

Medical Subject Heading (MeSH) Categories for 062713

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 062713

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEPHALEXIN	cephalexin	CAPSULE;ORAL	062713	ANDA	AvKARE	42291-208	42291-208-50	500 CAPSULE in 1 BOTTLE (42291-208-50)
CEPHALEXIN	cephalexin	CAPSULE;ORAL	062713	ANDA	AvKARE	42291-209	42291-209-50	500 CAPSULE in 1 BOTTLE (42291-209-50)

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

Complete Access Available with Subscription