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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210105

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NDA 210105 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 210105

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

Pharmacology for NDA: 210105

Suppliers and Packaging for NDA: 210105

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BEXAROTENE	bexarotene	CAPSULE;ORAL	210105	ANDA	AvKARE	42291-072	42291-072-01	100 CAPSULE in 1 BOTTLE (42291-072-01)
BEXAROTENE	bexarotene	CAPSULE;ORAL	210105	ANDA	Amneal Pharmaceuticals NY LLC	69238-1250	69238-1250-1	1 BOTTLE in 1 CARTON (69238-1250-1) / 100 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Sep 4, 2018	TE:	AB	RLD:	No

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