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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202590

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NDA 202590 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 fifty-nine 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-five suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 202590

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202590

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202590 ANDA Heritage Pharmaceuticals Inc. 23155-201 23155-201-31 1 VIAL, GLASS in 1 CARTON (23155-201-31) > 20 mL in 1 VIAL, GLASS
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202590 ANDA Heritage Pharmaceuticals Inc. 23155-201 23155-201-32 1 VIAL, GLASS in 1 CARTON (23155-201-32) > 30 mL in 1 VIAL, GLASS

Summary for product number 001

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

Summary 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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