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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090836


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NDA 090836 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, and Yung Shin Pharm, and is included in fifty NDAs. It is available from thirty-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. Thirty-three 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 Major Pharmaceuticals 0904-7336 0904-7336-61 100 BLISTER PACK in 1 CARTON (0904-7336-61) / 1 CAPSULE in 1 BLISTER PACK
CEPHALEXIN cephalexin CAPSULE;ORAL 090836 ANDA Major Pharmaceuticals 0904-7337 0904-7337-06 50 BLISTER PACK in 1 CARTON (0904-7337-06) / 1 CAPSULE in 1 BLISTER PACK

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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