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Federal Trade Commission
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Dow
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Colorcon

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064085

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NDA 064085 describes CEFACLOR, which is a drug marketed by Ceph Intl, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Watson Labs Inc, Yung Shin Pharm, Facta Farma, and World Gen, and is included in twenty-nine NDAs. It is available from twelve suppliers. Additional details are available on the CEFACLOR profile page.

The generic ingredient in CEFACLOR is cefaclor. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the cefaclor profile page.
Summary for 064085
Tradename:CEFACLOR
Applicant:Ivax Sub Teva Pharms
Ingredient:cefaclor
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 064085

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Apr 28, 1995TE:RLD:No

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