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Last Updated: November 4, 2024

Pharmaceutical drugs supplied by: Amicus Therapeutics US, LLC

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Amicus Therapeutics US, LLC

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623	NDA	Amicus Therapeutics US, LLC	71904-100-01	14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK	2018-08-10
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211	NDA	AMICUS THERAPEUTICS US, LLC	71904-300-01	4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC	2023-10-11
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211	NDA	AMICUS THERAPEUTICS US, LLC	71904-300-02	24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC	2023-10-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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