Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       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 | Best Phone © 2012 Betterchem.com