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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Deloitte
Farmers Insurance
Chubb
Cantor Fitzgerald
McKinsey
Argus Health
Chinese Patent Office
Johnson and Johnson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076527

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NDA 076527 describes OFLOXACIN, which is a drug marketed by Bedford, Akorn, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Fdc Ltd, Hi Tech Pharma, Sandoz, Sandoz Inc, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty NDAs. It is available from thirty-four suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 076527
Tradename:OFLOXACIN
Applicant:Apotex Inc
Ingredient:ofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 076527
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 076527 ANDA A-S Medication Solutions 50090-1090 50090-1090-0 5 mL in 1 BOTTLE, DROPPER (50090-1090-0)
OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 076527 ANDA Apotex Corp. 60505-0363 60505-0363-2 10 mL in 1 BOTTLE, DROPPER (60505-0363-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength0.3%
Approval Date:Sep 28, 2007TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

McKinsey
Cipla
US Army
Colorcon
Fuji
Accenture
Deloitte
Daiichi Sankyo
QuintilesIMS

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