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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fuji
Cantor Fitzgerald
US Department of Justice
Colorcon
Harvard Business School
Fish and Richardson
Citi
Cipla

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021537

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NDA 021537 describes CIPRODEX, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CIPRODEX profile page.

The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 021537
Tradename:CIPRODEX
Applicant:Novartis Pharms Corp
Ingredient:ciprofloxacin; dexamethasone
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021537
Ingredient-typeQuinolones
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 021537
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537 NDA Alcon Laboratories, Inc. 0065-8533 N 0065-8533-02
CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537 NDA Alcon Laboratories, Inc. 0065-8533 N 0065-8533-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength0.3%;0.1%
Approval Date:Jul 18, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 10, 2020Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Aug 10, 2020Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jun 4, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS MEDIA

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Cantor Fitzgerald
UBS
Express Scripts
McKesson
Cipla
Argus Health
Merck

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