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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 are two patents protecting this drug. Additional details are available on the ELIDEL profile page.

The generic ingredient in ELIDEL is pimecrolimus. There are four 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 NDA: 021302

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
CREAM;TOPICAL 021302 NDA Valeant Pharmaceuticals North America LLC 0187-5100 0187-5100-01 1 TUBE in 1 CARTON (0187-5100-01) > 30 g in 1 TUBE
CREAM;TOPICAL 021302 NDA Valeant Pharmaceuticals North America LLC 0187-5101 0187-5101-02 1 TUBE in 1 CARTON (0187-5101-02) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 13, 2001TE:RLD:Yes
Patent:5,912,238*PEDPatent Expiration:Dec 15, 2016Product Flag?Substance Flag?Delist Request?
Patent:6,423,722*PEDPatent Expiration:Dec 26, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021302

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda
CREAM;TOPICAL021302-001Dec 13, 20015,912,238*PED► subscribe
Valeant Bermuda
CREAM;TOPICAL021302-001Dec 13, 20016,352,998*PED► subscribe
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