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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Deloitte
Harvard Business School
Mallinckrodt
Argus Health
Merck
Fish and Richardson
Baxter
Medtronic

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090836

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NDA 090836 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 thirty-nine 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. Forty-one suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 090836
Tradename:CEPHALEXIN
Applicant:Alkem Labs Ltd
Ingredient:cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090836
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 090836
Suppliers and Packaging for NDA: 090836
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin CAPSULE;ORAL 090836 ANDA Crown Laboratories, Inc. 0316-0333 N 0316-0333-10
CEPHALEXIN cephalexin CAPSULE;ORAL 090836 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-978 N 35356-978-75

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Dec 20, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Dec 20, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 333MG BASE
Approval Date:Mar 29, 2013TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Julphar
Cantor Fitzgerald
Cerilliant
Fish and Richardson
Boehringer Ingelheim
Johnson and Johnson
UBS
Daiichi Sankyo

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