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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 062713


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NDA 062713 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-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 062713
Tradename:CEPHALEXIN
Applicant:Belcher Pharms
Ingredient:cephalexin
Patents:0
Pharmacology for NDA: 062713
Medical Subject Heading (MeSH) Categories for 062713
Suppliers and Packaging for NDA: 062713
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin CAPSULE;ORAL 062713 ANDA AvKARE 42291-208 42291-208-50 500 CAPSULE in 1 BOTTLE (42291-208-50)
CEPHALEXIN cephalexin CAPSULE;ORAL 062713 ANDA AvKARE 42291-209 42291-209-50 500 CAPSULE in 1 BOTTLE (42291-209-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Jul 15, 1988TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Jul 15, 1988TE:ABRLD:No

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