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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022185

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NDA 022185 describes TACLONEX, which is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TACLONEX profile page.

The generic ingredient in TACLONEX is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 022185
Tradename:TACLONEX
Applicant:Leo Pharma As
Ingredient:betamethasone dipropionate; calcipotriene
Patents:2
Pharmacology for NDA: 022185
Suppliers and Packaging for NDA: 022185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185 NDA LEO Pharma Inc. 50222-501 50222-501-06 40 CARTON in 1 CASE (50222-501-06) > 1 BOTTLE in 1 CARTON > 60 g in 1 BOTTLE
TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185 NDA LEO Pharma Inc. 50222-501 50222-501-51 40 CARTON in 1 CASE (50222-501-51) > 1 BOTTLE in 1 CARTON > 4 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.064%;0.005%
Approval Date:May 9, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 25, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 25, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PLAQUE PSORIASIS

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