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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Boehringer Ingelheim
Fish and Richardson
Federal Trade Commission
Deloitte
Novartis
Teva
Fuji
Chubb

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076407

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NDA 076407 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 076407

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

Pharmacology for NDA: 076407

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 076407

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076407 ANDA Henry Schein Inc. 0404-7189 0404-7189-01 1 BOTTLE, DROPPER in 1 CARTON (0404-7189-01) > 10 mL in 1 BOTTLE, DROPPER
OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076407 ANDA MWI 13985-602 13985-602-10 1 BOTTLE, DROPPER in 1 CARTON (13985-602-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Apr 15, 2008TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
UBS
Mallinckrodt
Citi
Argus Health
Deloitte
QuintilesIMS
Accenture
Baxter
Novartis

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