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Last Updated: November 4, 2024

Pharmaceutical drugs supplied by: Actelion Pharmaceuticals US, Inc.

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Actelion Pharmaceuticals US, Inc.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-101-03	10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK	2001-11-20
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-101-06	1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2001-11-20
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-102-03	10 BLISTER PACK in 1 CARTON (66215-102-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK	2001-11-20
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-102-06	1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2001-11-20
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279	NDA	Actelion Pharmaceuticals US, Inc.	66215-103-56	4 BLISTER PACK in 1 CARTON (66215-103-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-103-14)	2017-11-13
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348	NDA	Actelion Pharmaceuticals US, Inc.	66215-201-90	6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)	2003-07-31
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279	NDA	Actelion Pharmaceuticals US, Inc.	66215-232-56	4 BLISTER PACK in 1 CARTON (66215-232-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-232-14)	2021-07-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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