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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 213597

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NDA 213597 describes OFLOXACIN, which is a drug marketed by Bedford, Altaire Pharms Inc, Alvogen, Amneal, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Sandoz, Sentiss, Somerset, Hikma, Somerset Theraps Llc, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in twenty-nine NDAs. It is available from thirty suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN 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 213597

Tradename:	OFLOXACIN
Applicant:	Somerset
Ingredient:	ofloxacin
Patents:	0

Pharmacology for NDA: 213597

Medical Subject Heading (MeSH) Categories for 213597

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

Suppliers and Packaging for NDA: 213597

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	213597	ANDA	Somerset Therapeutics, LLC	70069-411	70069-411-01	1 BOTTLE in 1 CARTON (70069-411-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Aug 1, 2024	TE:	AT	RLD:	No

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