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Last Updated: November 4, 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:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Jun 16, 2020	TE:	AB	RLD:	No

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