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Details for New Drug Application (NDA): 021055

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NDA 021055 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: 021055

Tradename:
TARGRETIN
Applicant:
Valeant Luxembourg
Ingredient:
bexarotene
Patents:2
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021055

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 021055

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TARGRETIN
bexarotene
CAPSULE;ORAL 021055 NDA Valeant Pharmaceuticals North America LLC 0187-5526 0187-5526-75 1 BOTTLE in 1 CARTON (0187-5526-75) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE
TARGRETIN
bexarotene
CAPSULE;ORAL 021055 NDA Eisai Inc. 62856-602 62856-602-10 1 BOTTLE in 1 CARTON (62856-602-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Dec 29, 1999TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 29, 2018
Regulatory Exclusivity Use:REVISES THE CLINICAL TRIALS SECTION OF THE PRESCRIBING INFORMATION TO INCORPORATE THE RESULTS FROM STUDY E7273-G000-401 ENTITLED 'PHASE IV RANDOMIZED STUDY OF TWO DOSE LEVELS OF TARGRETIN CAPSULES IN SUBJECTS WITH REFRACTORY CUTANEOUS T-CELL LYMPHOMA'
Patent:5,780,676Patent Expiration:Jul 14, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
Patent:5,962,731Patent Expiration:Oct 5, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY

Expired Orange Book Patents for NDA: 021055

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 19995,466,861► subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 19996,043,279► subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 19997,655,699► 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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