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Serving leading biopharmaceutical companies globally:

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Generated: January 18, 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, Sagent Agila Llc, Zydus Pharms Usa Inc, Apotex Inc, 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, Acs Dobfar Info Sa, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in thirty-six NDAs. It is available from sixty-one suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are twenty-nine drug master file entries for this compound. Sixty-seven 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 0781-5790-50 50 TABLET, FILM COATED in 1 BOTTLE (0781-5790-50)
LEVOFLOXACIN levofloxacin TABLET;ORAL 077438 ANDA Sandoz Inc 0781-5790 0781-5790-10 1000 TABLET, FILM COATED in 1 BOTTLE (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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