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Last Updated: January 16, 2021

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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. 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. 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

Profile for product number 001

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

Expired US Patents for NDA 022185

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008   Start Trial   Start Trial
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008   Start Trial   Start Trial
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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