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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 216328

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NDA 216328 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 216328

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

Pharmacology for NDA: 216328

Medical Subject Heading (MeSH) Categories for 216328

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

Suppliers and Packaging for NDA: 216328

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OFLOXACIN	ofloxacin	SOLUTION/DROPS;OTIC	216328	ANDA	Redpharm Drug	67296-2179	67296-2179-5	1 BOTTLE in 1 CARTON (67296-2179-5) / 5 mL in 1 BOTTLE
OFLOXACIN	ofloxacin	SOLUTION/DROPS;OTIC	216328	ANDA	Preferred Pharmaceuticals Inc.	68788-4086	68788-4086-1	1 BOTTLE in 1 CARTON (68788-4086-1) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OTIC			Strength	0.3%
Approval Date:	Oct 15, 2024	TE:	AT	RLD:	No

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