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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076890

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NDA 076890 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-seven 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-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 076890

Tradename:	LEVOFLOXACIN
Applicant:	Chartwell Molecular
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 076890

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

Suppliers and Packaging for NDA: 076890

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOFLOXACIN	levofloxacin	TABLET;ORAL	076890	ANDA	Chartwell RX, LLC	62135-655	62135-655-14	14 TABLET in 1 BOTTLE (62135-655-14)
LEVOFLOXACIN	levofloxacin	TABLET;ORAL	076890	ANDA	Chartwell RX, LLC	62135-656	62135-656-50	50 TABLET in 1 BOTTLE (62135-656-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Mar 30, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Mar 30, 2012	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Mar 30, 2012	TE:	AB	RLD:	No

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