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Generated: December 17, 2017

DrugPatentWatch Database Preview

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 two 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 six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the bexarotene profile page.

Summary for 021056

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021056

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 021056

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TARGRETIN bexarotene GEL;TOPICAL 021056 NDA Valeant Pharmaceuticals North America LLC 0187-5525 0187-5525-60 60 g in 1 TUBE (0187-5525-60)
TARGRETIN bexarotene GEL;TOPICAL 021056 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-002 68682-002-60 60 g in 1 TUBE (68682-002-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Jun 28, 2000TE:RLD:Yes
Patent:► SubscribePatent 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 LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Moodys
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US Army
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