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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Fuji
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Daiichi Sankyo
Express Scripts
Johnson and Johnson

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078222

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NDA 078222 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-two suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 078222
Tradename:OFLOXACIN
Applicant:Sandoz Inc
Ingredient:ofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 078222
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 078222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 078222 ANDA Falcon Pharmaceuticals, Ltd. 61314-015 E 61314-015-05
OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 078222 ANDA Falcon Pharmaceuticals, Ltd. 61314-015 E 61314-015-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength0.3%
Approval Date:Mar 17, 2008TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Covington
McKinsey
Citi
Deloitte
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Chubb
Teva
Accenture

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