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Generated: May 25, 2018

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 three 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 hydrate. There are sixty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene hydrate profile page.
Summary for 022185
Tradename:TACLONEX
Applicant:Leo Pharma As
Ingredient:betamethasone dipropionate; calcipotriene hydrate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022185
Ingredient-typeVitamin D
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 022185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACLONEX betamethasone dipropionate; calcipotriene hydrate SUSPENSION;TOPICAL 022185 NDA LEO Pharma Inc. 50222-501 N 50222-501-06
TACLONEX betamethasone dipropionate; calcipotriene hydrate SUSPENSION;TOPICAL 022185 NDA LEO Pharma Inc. 50222-501 N 50222-501-51

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.064%;0.005%
Approval Date:May 9, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PLAQUE PSORIASIS
Patent:➤ Try a Free TrialPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PSORIASIS
Patent:➤ Try a Free TrialPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE PLAQUE PSORIASIS

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
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Healthtrust
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