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Last Updated: December 15, 2025

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, Cipla, Hikma, Teva Pharms Usa, Upsher Smith Labs, and Amneal, and is included in nine NDAs. It is available from seven 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. Eight 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Jun 16, 2020	TE:	AB	RLD:	No

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