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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020799

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NDA 020799 describes FLOXIN OTIC, which is a drug marketed by Daiichi and is included in one NDA. Additional details are available on the FLOXIN OTIC profile page.

The generic ingredient in FLOXIN OTIC is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 020799
Tradename:FLOXIN OTIC
Applicant:Daiichi
Ingredient:ofloxacin
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 020799
Tradename Dosage Ingredient NDA Submissiondate
FLOXIN OTIC SOLUTION/DROPS;OTIC ofloxacin 020799

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OTICStrength0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 16, 1997TE:RLD:Yes

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