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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 205968

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NDA 205968 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 Inc, 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 205968

Tradename:	LEVOFLOXACIN
Applicant:	Zydus Pharms
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 205968

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:	INJECTABLE;INJECTION			Strength	EQ 500MG/20ML (EQ 25MG/ML)
Approval Date:	Jun 1, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 750MG/30ML (EQ 25MG/ML)
Approval Date:	Jun 1, 2017	TE:		RLD:	No

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