BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
US Department of Justice

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076826

« Back to Dashboard

NDA 076826 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-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 076826
Applicant:Watson Labs Teva
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 076826 ANDA Hi-Tech Pharmacal Co., Inc. 50383-283 N 50383-283-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Feb 10, 2011TE:ATRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson

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.