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Deloitte
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US Department of Justice
Covington

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065081

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NDA 065081 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-three 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-six suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 065081
Tradename:CEPHALEXIN
Applicant:Sun Pharm Inds Ltd
Ingredient:cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065081
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065081
Suppliers and Packaging for NDA: 065081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 065081 ANDA Physicians Total Care, Inc. 54868-0538 E 54868-0538-1
CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 065081 ANDA Physicians Total Care, Inc. 54868-0538 E 54868-0538-2

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Jul 27, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Jul 27, 2001TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Daiichi Sankyo
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Johnson and Johnson
Express Scripts
Mallinckrodt
Chinese Patent Office
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