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Last Updated: January 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076622

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NDA 076622 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-one 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-two suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 076622
Tradename:OFLOXACIN
Applicant:Bausch And Lomb
Ingredient:ofloxacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076622
Suppliers and Packaging for NDA: 076622
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076622 ANDA Bausch & Lomb Incorporated 24208-434 24208-434-05 1 BOTTLE, DROPPER in 1 CARTON (24208-434-05) > 5 mL in 1 BOTTLE, DROPPER
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076622 ANDA Bausch & Lomb Incorporated 24208-434 24208-434-10 1 BOTTLE, DROPPER in 1 CARTON (24208-434-10) > 10 mL in 1 BOTTLE, DROPPER

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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