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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 090787

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NDA 090787 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-one 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-seven suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 090787

Tradename:	LEVOFLOXACIN
Applicant:	Apotex Inc
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 090787

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Sep 29, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Sep 29, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Sep 29, 2011	TE:	AB	RLD:	No

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