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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021302


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NDA 021302 describes ELIDEL, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the ELIDEL profile page.

The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
Summary for 021302
Tradename:ELIDEL
Applicant:Bausch
Ingredient:pimecrolimus
Patents:0
Pharmacology for NDA: 021302
Mechanism of ActionCalcineurin Inhibitors
Suppliers and Packaging for NDA: 021302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIDEL pimecrolimus CREAM;TOPICAL 021302 NDA Bausch Health US, LLC 0187-5100 0187-5100-01 1 TUBE in 1 CARTON (0187-5100-01) / 30 g in 1 TUBE
ELIDEL pimecrolimus CREAM;TOPICAL 021302 NDA Bausch Health US, LLC 0187-5101 0187-5101-02 1 TUBE in 1 CARTON (0187-5101-02) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 13, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021302

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 ⤷  Sign Up ⤷  Sign Up
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 ⤷  Sign Up ⤷  Sign Up
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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