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FDA Approval Activities for this Drug… Flolan (epoprostenol sodium) Injection, Glaxo Wellcome NDA 20-444/S-003 4/14/00 4/17/00 4/17/00 1/7/02 Flolan Indication: Long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III & Class IV patients who do not respond to conventional therapy. | FLOLAN (epoprostenol sodium) Injection, GlaxoSmithKline, Labeling Revision | Epoprostenol Sodium Injection, Teva Parenteral, Approval | Epoprostenol Injection, GeneraMedix, Inc., Approval | Epoprostenol Sodium Injection, Actelion, Ltd., Labeling Revision | Veletri (epoprostenol sodium) Injection, Actelion Ltd., Labeling Revision | Flolan (epoprostenol sodium) Injection, GlaxoSmithKline LLC, 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