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Details for New Drug Application (NDA): 021056

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NDA 021056 describes TARGRETIN, which is a drug marketed by Valeant Luxembourg and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the TARGRETIN profile page.

The generic ingredient in TARGRETIN is bexarotene. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the bexarotene profile page.

Summary for NDA: 021056

Valeant Luxembourg
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021056


Suppliers and Packaging for NDA: 021056

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 021056 NDA Valeant Pharmaceuticals North America LLC 0187-5525 0187-5525-60 60 g in 1 TUBE (0187-5525-60)
GEL;TOPICAL 021056 NDA Eisai Inc. 62856-604 62856-604-22 60 g in 1 TUBE (62856-604-22)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Jun 28, 2000TE:RLD:Yes
Patent:5,962,731Patent Expiration:Oct 5, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021056

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg
GEL;TOPICAL021056-001Jun 28, 20005,466,861► subscribe
Valeant Luxembourg
GEL;TOPICAL021056-001Jun 28, 20006,043,279► subscribe
Valeant Luxembourg
GEL;TOPICAL021056-001Jun 28, 20006,320,074► subscribe
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