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US Army
Express Scripts

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021302

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NDA 021302 describes ELIDEL, which is a drug marketed by Valeant Bermuda and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. 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. Two suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.
Summary for 021302
Applicant:Valeant Bermuda
Therapeutic Class:Dermatological Agents
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 Valeant Pharmaceuticals North America LLC 0187-5100 N 0187-5100-01
ELIDEL pimecrolimus CREAM;TOPICAL 021302 NDA Valeant Pharmaceuticals North America LLC 0187-5101 N 0187-5101-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 13, 2001TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 26, 2018Product Flag?Substance Flag?Delist Request?Y

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Fish and Richardson
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