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Last Updated: May 31, 2020

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Details for New Drug Application (NDA): 205222

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NDA 205222 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 205222
Applicant:Lannett Co Inc
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin SOLUTION;ORAL 205222 ANDA Pharmaceutical Associates, Inc. 0121-0872 0121-0872-20 2 CASE in 1 CASE (0121-0872-20) > 4 TRAY in 1 CASE (0121-0872-40) > 10 CUP in 1 TRAY (0121-0872-10) > 10 mL in 1 CUP
LEVOFLOXACIN levofloxacin SOLUTION;ORAL 205222 ANDA Lannett Company, Inc. 0527-1948 0527-1948-66 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) > 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/10ML
Approval Date:May 25, 2018TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

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