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Serving leading biopharmaceutical companies globally:

Argus Health
Fuji
Fish and Richardson
Chubb
Julphar
UBS
Colorcon
Medtronic
Boehringer Ingelheim
Queensland Health

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076710

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NDA 076710 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 sixty-one 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-seven suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 076710
Tradename:LEVOFLOXACIN
Applicant:Dr Reddys Labs Inc
Ingredient:levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 076710
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076710
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6351 0904-6351-61 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6351-61)
LEVOFLOXACIN levofloxacin TABLET;ORAL 076710 ANDA Major Pharmaceuticals 0904-6352 0904-6352-61 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6352-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jun 20, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
Harvard Business School
Novartis
Dow
Covington
Cantor Fitzgerald
Medtronic
QuintilesIMS
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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