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Last Updated: November 2, 2024

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 two suppliers. 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. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 021852
Tradename:TACLONEX
Applicant:Leo Pharma As
Ingredient:betamethasone dipropionate; calcipotriene
Patents:0
Suppliers and Packaging for NDA: 021852
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-938 66993-938-61 1 TUBE in 1 CARTON (66993-938-61) / 60 g in 1 TUBE
TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-938 66993-938-65 1 TUBE in 1 CARTON (66993-938-65) / 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.064%;0.005%
Approval Date:Jan 9, 2006TE:ABRLD:Yes

Expired US Patents for NDA 021852

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 ⤷  Sign Up ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 ⤷  Sign Up ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 ⤷  Sign Up ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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