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Last Updated: January 23, 2020

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, Amneal, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-one NDAs. It is available from twenty suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty-one 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 076527
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 60505-0363-1 5 mL in 1 BOTTLE, DROPPER (60505-0363-1)

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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