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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209861

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NDA 209861 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 209861

Tradename:	BEXAROTENE
Applicant:	Ani Pharms
Ingredient:	bexarotene
Patents:	0

Pharmacology for NDA: 209861

Suppliers and Packaging for NDA: 209861

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BEXAROTENE	bexarotene	CAPSULE;ORAL	209861	ANDA	ANI Pharmaceuticals, Inc.	43975-315	43975-315-10	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	May 8, 2018	TE:	AB	RLD:	No

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