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Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203613

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NDA 203613 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-two suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 203613
Tradename:LEVOFLOXACIN
Applicant:Jubilant Generics
Ingredient:levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203613
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 203613 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-513 N 59746-513-06
LEVOFLOXACIN levofloxacin TABLET;ORAL 203613 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-513 N 59746-513-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 19, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 19, 2015TE:ABRLD:No

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