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Last Updated: December 16, 2025

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

Medical Subject Heading (MeSH) Categories for 020799

Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OTIC			Strength	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 16, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020799

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Daiichi	FLOXIN OTIC	ofloxacin	SOLUTION/DROPS;OTIC	020799-001	Dec 16, 1997	5,401,741	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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