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 hydrate. 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 hydrate profile page.

Summary for 022185

Tradename:	TACLONEX
Applicant:	Leo Pharma As
Ingredient:	betamethasone dipropionate; calcipotriene hydrate
Patents:	2

Pharmacology for NDA: 022185

Mechanism of Action	Corticosteroid 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	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 hydrate	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:	RX	Dosage:	SUSPENSION;TOPICAL			Strength	0.064%;0.005%
Approval Date:	May 9, 2008	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Jan 27, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	PLAQUE PSORIASIS
Patent:	➤ Try a Free Trial	Patent Expiration:	Jan 27, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	PSORIASIS
Patent:	➤ Try a Free Trial	Patent Expiration:	Jan 27, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MODERATE PLAQUE PSORIASIS

Expired US Patents for NDA 022185

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

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