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Queensland Health
Colorcon
Fuji
Harvard Business School
Julphar
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QuintilesIMS
Cipla

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022212

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NDA 022212 describes DUREZOL, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DUREZOL profile page.

The generic ingredient in DUREZOL is difluprednate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the difluprednate profile page.
Summary for 022212
Tradename:DUREZOL
Applicant:Novartis Pharms Corp
Ingredient:difluprednate
Patents:1
Suppliers and Packaging for NDA: 022212
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUREZOL difluprednate EMULSION;OPHTHALMIC 022212 NDA Alcon Laboratories, Inc. 0065-9240 N 0065-9240-07
DUREZOL difluprednate EMULSION;OPHTHALMIC 022212 NDA Alcon Laboratories, Inc. 0065-9240 N 0065-9240-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Jun 23, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 13, 2019
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jun 13, 2019
Regulatory Exclusivity Use:TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS
Patent:➤ Sign UpPatent Expiration:Nov 18, 2019Product Flag?Substance Flag?Delist Request?Y

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