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Generated: November 18, 2018

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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 one supplier. 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 four drug master file entries for this compound. One supplier is 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
Generic Entry Opportunity Date for 022212
Generic Entry Date for 022212*:
Constraining patent/regulatory exclusivity:
PEDIATRIC EXCLUSIVITY
Dosage:
EMULSION;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 0065-9240-07 1 BOTTLE in 1 CARTON (0065-9240-07) > 5 mL in 1 BOTTLE
DUREZOL difluprednate EMULSION;OPHTHALMIC 022212 NDA Alcon Laboratories, Inc. 0065-9240 0065-9240-08 1 BOTTLE in 1 CARTON (0065-9240-08) > 1 mL in 1 BOTTLE

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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