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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 091436

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NDA 091436 describes LEVOFLOXACIN, which is a drug marketed by Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, 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 forty 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-six suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 091436

Tradename:	LEVOFLOXACIN
Applicant:	Baxter Hlthcare Corp
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 091436

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

Suppliers and Packaging for NDA: 091436

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	091436	ANDA	Baxter Healthcare Corporation	36000-045	36000-045-01	20 mL in 1 VIAL, SINGLE-USE (36000-045-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG/20ML (EQ 25MG/ML)
Approval Date:	Jun 5, 2013	TE:		RLD:	No

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