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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Citi
Julphar
UBS
Merck
US Army
Moodys
McKesson
Deloitte

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076615

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NDA 076615 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-three 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-four suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

Summary for 076615

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 076615

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 076615

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076615 ANDA STAT RX LLC USA 16590-175 16590-175-05 5 mL in 1 BOTTLE, DROPPER (16590-175-05)
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076615 ANDA Hi-Tech Pharmacal Co., Inc. 50383-024 50383-024-10 1 BOTTLE, DROPPER in 1 CARTON (50383-024-10) > 10 mL in 1 BOTTLE, DROPPER

Summary 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:

Cerilliant
Fish and Richardson
Farmers Insurance
Julphar
Teva
Accenture
McKesson
Cipla
QuintilesIMS
Covington

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