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Last Updated: November 21, 2024

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. Thirty-one 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

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 16, 1997TE:RLD:Yes

Expired US Patents for NDA 020799

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi FLOXIN OTIC ofloxacin SOLUTION/DROPS;OTIC 020799-001 Dec 16, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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