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Last Updated: January 28, 2022

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 fifty NDAs. It is available from thirty-one 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-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
Formulation / Manufacturing:see details
Pharmacology for NDA: 090836
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 QPharma Inc 42708-070 42708-070-28 28 CAPSULE in 1 BOTTLE (42708-070-28)
CEPHALEXIN cephalexin CAPSULE;ORAL 090836 ANDA QPharma Inc 42708-145 42708-145-28 28 CAPSULE in 1 BOTTLE (42708-145-28)

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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