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Last Updated: May 25, 2020

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Details for New Drug Application (NDA): 076890


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NDA 076890 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 076890
Tradename:LEVOFLOXACIN
Applicant:Cipla Ltd
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076890
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA DIRECT RX 61919-440 61919-440-14 14 TABLET in 1 BOTTLE (61919-440-14)
LEVOFLOXACIN levofloxacin TABLET;ORAL 076890 ANDA Proficient Rx LP 63187-384 63187-384-05 5 TABLET in 1 BOTTLE (63187-384-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 30, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 30, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Mar 30, 2012TE:ABRLD:No

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