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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 211524

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NDA 211524 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 211524

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

Pharmacology for NDA: 211524

Medical Subject Heading (MeSH) Categories for 211524

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

Suppliers and Packaging for NDA: 211524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	211524	ANDA	Amneal Pharmaceuticals NY LLC	69238-1665	69238-1665-6	1 BOTTLE, DROPPER in 1 CARTON (69238-1665-6) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

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

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