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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200250


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NDA 200250 describes LEVOFLOXACIN, which is a drug marketed by Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Mylan Asi, Rising, Zydus Pharms, Akorn, Micro Labs Ltd India, Mylan Labs Ltd, Rubicon, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Celltrion, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, 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-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 200250
Tradename:LEVOFLOXACIN
Applicant:Glenmark Generics
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jun 20, 2011TE:ABRLD:No

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