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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
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Dow
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Harvard Business School
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McKinsey
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Fish and Richardson

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065326

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NDA 065326 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Apothecon, Aurobindo Pharma Ltd, Barr, Belcher Pharms, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Orchid Hlthcare, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Yung Shin Pharm, Hikma Pharms, and Vitarine, and is included in forty-nine NDAs. It is available from sixty 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. Sixty-three suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 065326
Tradename:CEPHALEXIN
Applicant:Orchid Hlthcare
Ingredient:cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065326
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065326
Suppliers and Packaging for NDA: 065326
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 065326 ANDA OrchidPharma Inc 42043-142 N 42043-142-38
CEPHALEXIN cephalexin FOR SUSPENSION;ORAL 065326 ANDA OrchidPharma Inc 42043-142 N 42043-142-58

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Jul 10, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Jul 10, 2006TE:ABRLD:No

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