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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Chubb
Healthtrust
Fuji
Johnson and Johnson
McKesson
US Army
Merck
Cipla

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076231

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NDA 076231 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 076231
Tradename:OFLOXACIN
Applicant:Sandoz Inc
Ingredient:ofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 076231
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076231 ANDA Falcon Pharmaceuticals, Ltd. 61314-012 61314-012-10 10 mL in 1 BOTTLE, PLASTIC (61314-012-10)
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076231 ANDA Falcon Pharmaceuticals, Ltd. 61314-012 61314-012-05 5 mL in 1 BOTTLE, PLASTIC (61314-012-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:May 14, 2004TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
Argus Health
Accenture
Fish and Richardson
AstraZeneca
Colorcon
Citi
Julphar
Queensland Health

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