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Last Updated: May 31, 2020

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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, Apotex Inc, Micro Labs Ltd India, Mylan Labs Ltd, Rising, Watson Labs Teva, Hi Tech Pharma, Lannett Co Inc, Celltrion, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife, and is included in forty NDAs. It is available from forty-seven 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. Fifty-three 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
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 55150-156-20 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) > 20 mL in 1 VIAL, SINGLE-USE
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328 ANDA AuroMedics Pharma LLC 55150-157 55150-157-30 1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) > 30 mL in 1 VIAL, SINGLE-USE

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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