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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 062702


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NDA 062702 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-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 062702
Tradename:CEPHALEXIN
Applicant:Teva
Ingredient:cephalexin
Patents:0
Pharmacology for NDA: 062702
Medical Subject Heading (MeSH) Categories for 062702
Suppliers and Packaging for NDA: 062702
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin CAPSULE;ORAL 062702 ANDA Teva Pharmaceuticals USA, Inc. 0093-3145 0093-3145-01 100 CAPSULE in 1 BOTTLE (0093-3145-01)
CEPHALEXIN cephalexin CAPSULE;ORAL 062702 ANDA Teva Pharmaceuticals USA, Inc. 0093-3145 0093-3145-05 500 CAPSULE in 1 BOTTLE (0093-3145-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Feb 13, 1987TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Feb 13, 1987TE:ABRLD:No

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