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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 203663


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NDA 203663 describes BEXAROTENE, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hikma, Teva Pharms Usa, Upsher Smith Labs, and Amneal, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the BEXAROTENE profile page.

The generic ingredient in BEXAROTENE is bexarotene. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
Summary for 203663
Tradename:BEXAROTENE
Applicant:Hikma
Ingredient:bexarotene
Patents:0
Pharmacology for NDA: 203663
Suppliers and Packaging for NDA: 203663
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEXAROTENE bexarotene CAPSULE;ORAL 203663 ANDA Hikma Pharmaceuticals USA Inc. 0054-0399 0054-0399-25 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0054-0399-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Jun 16, 2020TE:ABRLD:No

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