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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 are two patents 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

Tradename:
TARGRETIN
Applicant:
Valeant Luxembourg
Ingredient:
bexarotene
Patents:2
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 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?
Patent:5,780,676Patent Expiration:Jul 14, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (STAGE IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES OR WHO HAVE NOT TOLERATED OTHER THERAPIES

Expired Orange Book Patents for NDA: 021056

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 20005,466,861► subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 20006,320,074► subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 20006,043,279► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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