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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 065081


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NDA 065081 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 065081
Tradename:CEPHALEXIN
Applicant:Sun Pharm Inds Ltd
Ingredient:cephalexin
Patents:0
Medical Subject Heading (MeSH) Categories for 065081

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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