Last Updated: June 25, 2026

Details for New Drug Application (NDA): 065229


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NDA 065229 describes CEPHALEXIN, which is a drug marketed by Ajenat Pharms, Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, 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-one NDAs. It is available from thirty-seven 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-seven 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
Pharmacology for NDA: 065229
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 Proficient Rx LP 63187-046 63187-046-06 6 CAPSULE in 1 BOTTLE (63187-046-06)
CEPHALEXIN cephalexin CAPSULE;ORAL 065229 ANDA Proficient Rx LP 63187-046 63187-046-14 14 CAPSULE in 1 BOTTLE (63187-046-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Nov 25, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Nov 25, 2005TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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