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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215398

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NDA 215398 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 215398

Tradename:	BEXAROTENE
Applicant:	Amneal
Ingredient:	bexarotene
Patents:	0

Pharmacology for NDA: 215398

Suppliers and Packaging for NDA: 215398

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BEXAROTENE	bexarotene	GEL;TOPICAL	215398	ANDA	Amneal Pharmaceuticals NY LLC	69238-2088	69238-2088-6	1 TUBE in 1 CARTON (69238-2088-6) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Apr 27, 2022	TE:	AB	RLD:	No

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