FDA Approval Activities for this Drug…

Tracleer (Bosentan) Tablets, Actelion, Ltd. NDA 21-290/S1 10/6/03 10/10/03 10/10/03 Tracleer (Bosentan) Tablets, (Consumer Safety Alert) Actelion, Ltd. NDA 21-290 11/20/01 2/1/02 2/1/02 2/1/02 Tracleer Indications: Treatment of pulmonary arterial hypertension. | Tracleer (bosentan) Tablets, Actelion Ltd., Labeling Revision

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