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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202801

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NDA 202801 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 202801

Tradename:	LEVOFLOXACIN
Applicant:	Hetero Labs Ltd V
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 202801

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

Suppliers and Packaging for NDA: 202801

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOFLOXACIN	levofloxacin	TABLET;ORAL	202801	ANDA	Camber Pharmaceuticals, Inc.	31722-721	31722-721-31	10 TABLET, FILM COATED in 1 BLISTER PACK (31722-721-31)
LEVOFLOXACIN	levofloxacin	TABLET;ORAL	202801	ANDA	Camber Pharmaceuticals, Inc.	31722-721	31722-721-32	100 TABLET, FILM COATED in 1 BLISTER PACK (31722-721-32)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jan 8, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 8, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Jan 8, 2015	TE:	AB	RLD:	No

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