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Last Updated: June 22, 2021

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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 Bausch 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
Applicant:Valeant Luxembourg
Formulation / Manufacturing:see details
Pharmacology for NDA: 021055
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 Bausch Health US, 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

Expired US Patents for NDA 021055

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Serving leading biopharmaceutical companies globally:

Express Scripts

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