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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 021537

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NDA 021537 describes CIPRODEX, which is a drug marketed by Novartis 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-four 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
Ingredient:ciprofloxacin; dexamethasone
Patents:6
Pharmacology for NDA: 021537
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 0065-8533-02 1 BOTTLE, DROPPER in 1 CARTON (0065-8533-02) > 7.5 mL in 1 BOTTLE, DROPPER
CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537 NDA Alcon Laboratories, Inc. 0065-8533 0065-8533-03 1 BOTTLE, DROPPER in 1 CARTON (0065-8533-03) > 1.5 mL in 1 BOTTLE, DROPPER
Paragraph IV (Patent) Challenges for 021537
Tradename Dosage Ingredient NDA Submissiondate
CIPRODEX SUSPENSION/DROPS;OTIC ciprofloxacin; dexamethasone 021537 2012-07-31

Profile for product number 001

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

Expired US Patents for NDA 021537

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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