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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020799

FLOXIN OTIC (OFLOXACIN)
0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OFLOXACIN
Proprietary Name: FLOXIN OTIC
Dosage Form; Route of Administration: SOLUTION/DROPS; OTIC
Strength: 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020799
Product Number: 001
Approval Date: Dec 16, 1997
Applicant Holder Full Name: DAIICHI PHARMACEUTICAL CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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