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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 | Tracleer (bosentan) Tablets, Actelion Ltd, Efficacy Supplement w/Clinical Data and Labeling Revision | Tracleer (bosentan) Tablets, Actelion Clinical, Efficacy Supp. w/Clinical Data | Tracleer (bosentan) Tablets, Actelion Clinical Research, Labeling Revision | Tracleer (bosentan) Tablets, Actelion Pharmaceuticals, Ltd., Labeling Revision | Tracleer (bosentan) Tablets, Actelion Pharmaceuticals, Ltd., Labeling Revision | Tracleer (bosentan) Tablets, Actelion Clinical Research, Inc., Supplement | Tracleer (bosentan) Tablets, Actelion, Ltd., Labeling | Tracleer (bosentan) Tablets, Actelion, Ltd., Labeling Revision View updates.                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | VOIP © 2012 Betterchem.com