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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065229

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NDA 065229 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Apothecon, Aurobindo Pharma Ltd, Barr, Belcher Pharms, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Orchid Hlthcare, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Yung Shin Pharm, Hikma Pharms, and Vitarine, and is included in forty-nine NDAs. It is available from sixty-two 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. Sixty-five suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

Summary for 065229

Tradename:	CEPHALEXIN
Applicant:	Lupin
Ingredient:	cephalexin
Patents:	0
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 065229

Ingredient-type	Cephalosporins

Medical Subject Heading (MeSH) Categories for 065229

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065229

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEPHALEXIN	cephalexin	CAPSULE;ORAL	065229	ANDA	Blenheim Pharmacal, Inc.	10544-013	E	10544-013-28
CEPHALEXIN	cephalexin	CAPSULE;ORAL	065229	ANDA	Blenheim Pharmacal, Inc.	10544-013	E	10544-013-40

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Nov 25, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Nov 25, 2005	TE:	AB	RLD:	No

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