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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202328

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NDA 202328 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 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 202328
Tradename:LEVOFLOXACIN
Applicant:Aurobindo Pharma Ltd
Ingredient:levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202328
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-156 N 55150-156-20
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-157 N 55150-157-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Jan 24, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/30ML (EQ 25MG/ML)
Approval Date:Jan 24, 2013TE:APRLD:No

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