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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cipla
Johnson and Johnson
Merck
Accenture
Federal Trade Commission
Daiichi Sankyo
Mallinckrodt
Citi

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077438

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NDA 077438 describes LEVOFLOXACIN, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Mylan Asi, Zydus Pharms Usa Inc, Apotex Inc, Mylan Labs Ltd, Rising Pharms Inc, Watson Labs Teva, Hi Tech Pharma, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Wockhardt, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife, and is included in thirty-seven NDAs. It is available from fifty-four suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 077438
Tradename:LEVOFLOXACIN
Applicant:Sandoz
Ingredient:levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077438
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5790 N 0781-5790-50
LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5790 N 0781-5790-10

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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Serving hundreds of leading biopharmaceutical companies globally:

Merck
AstraZeneca
Colorcon
Covington
Healthtrust
QuintilesIMS
Cerilliant
Baxter
Daiichi Sankyo

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