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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205222

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NDA 205222 describes LEVOFLOXACIN, which is a drug marketed by Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland, Hospira, Pharmobedient, Rising, Zydus Pharms, Micro Labs Ltd India, Rubicon Research, Sciegen Pharms, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Natco Pharma, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Lifesciences, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, and Knack, and is included in forty-three NDAs. It is available from thirty-eight suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 205222

Tradename:	LEVOFLOXACIN
Applicant:	Lannett Co Inc
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 205222

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

Suppliers and Packaging for NDA: 205222

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOFLOXACIN	levofloxacin	SOLUTION;ORAL	205222	ANDA	Lannett Company, Inc.	0527-1948	0527-1948-66	1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC
LEVOFLOXACIN	levofloxacin	SOLUTION;ORAL	205222	ANDA	Lannett Company, Inc.	0527-1948	0527-1948-68	1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	250MG/10ML
Approval Date:	May 25, 2018	TE:	AA	RLD:	No

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