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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 202328


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NDA 202328 describes LEVOFLOXACIN, which is a drug marketed by Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Natco Pharma, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Lifesciences, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, and Knack, and is included in forty-three NDAs. It is available from forty-two 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. Forty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 202328
Tradename:LEVOFLOXACIN
Applicant:Eugia Pharma
Ingredient:levofloxacin
Patents:0
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 Eugia US 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 Eugia US 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:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Jan 24, 2013TE:RLD:No

Profile for product number 002

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

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