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Details for New Drug Application (NDA): 021852

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NDA 021852 describes TACLONEX, which is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene hydrate profile page.

Summary for NDA: 021852

Tradename:
TACLONEX
Applicant:
Leo Pharma As
Ingredient:
betamethasone dipropionate; calcipotriene hydrate
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021852

Ingredient-typeVitamin D
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 021852

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL 021852 NDA Warner Chilcott (US), LLC 0430-3230 0430-3230-15 100 CARTON in 1 CASE (0430-3230-15) > 1 TUBE in 1 CARTON > 60 g in 1 TUBE
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL 021852 NDA Warner Chilcott (US), LLC 0430-3230 0430-3230-16 50 CARTON in 1 CASE (0430-3230-16) > 1 TUBE in 1 CARTON > 100 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.064%;0.005%
Approval Date:Jan 9, 2006TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 23, 2017
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:6,753,013Patent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PSORIASIS
Patent:6,753,013Patent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE PLAQUE PSORIASIS

Expired Orange Book Patents for NDA: 021852

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 20064,866,048► subscribe
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 2006RE39706► subscribe
Leo Pharma As
TACLONEX
betamethasone dipropionate; calcipotriene hydrate
OINTMENT;TOPICAL021852-001Jan 9, 20065,763,426► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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