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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 203174

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NDA 203174 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 203174

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

Pharmacology for NDA: 203174

Suppliers and Packaging for NDA: 203174

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BEXAROTENE	bexarotene	CAPSULE;ORAL	203174	ANDA	Mylan Pharmaceuticals Inc.	0378-6955	0378-6955-01	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Aug 12, 2014	TE:	AB	RLD:	No

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