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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 Alcon Pharms Ltd and is included in one NDA. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for NDA: 021537

Tradename:
CIPRODEX
Applicant:
Alcon Pharms Ltd
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 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength0.3%;0.1%
Approval Date:Jul 18, 2003TE:RLD:Yes
Patent:6,284,804Patent Expiration:Aug 10, 2020Product Flag?Substance Flag?Delist Request?
Patent:6,359,016Patent Expiration:Aug 10, 2020Product Flag?Substance Flag?Delist Request?
Patent:9,402,805Patent Expiration:Sep 13, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS EXTERNA

Expired Orange Book Patents for NDA: 021537

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
CIPRODEX
ciprofloxacin; dexamethasone
SUSPENSION/DROPS;OTIC021537-001Jul 18, 20034,844,902► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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