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Serving hundreds of leading biopharmaceutical companies globally:

Merck
UBS
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Colorcon
Cipla
US Army
Daiichi Sankyo
Federal Trade Commission
McKinsey

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077652

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NDA 077652 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 077652
Tradename:LEVOFLOXACIN
Applicant:Zydus Pharms Usa Inc
Ingredient:levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA Blenheim Pharmacal, Inc. 10544-451 E 10544-451-10
LEVOFLOXACIN levofloxacin TABLET;ORAL 077652 ANDA QPharma Inc 42708-063 N 42708-063-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Sep 7, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Sep 7, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Sep 7, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Mallinckrodt
Deloitte
Argus Health
Queensland Health
Cantor Fitzgerald
Fuji
Daiichi Sankyo
Accenture

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