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Generated: November 21, 2018

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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 two suppliers. Additional details are available on the TARGRETIN profile page.

The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
Summary for 021055
Tradename:TARGRETIN
Applicant:Valeant Luxembourg
Ingredient:bexarotene
Patents:0
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 AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-003 68682-003-10 1 BOTTLE in 1 CARTON (68682-003-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile 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'

Expired US Patents for NDA 021055

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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