FDA Approval Activities for this Drug…

Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-31 6/30/03 7/6/03 Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-29 11/19/02 11/22/02 Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-27 11/1/02 11/18/02 Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-21, S-22 & S-23 4/4/02 4/16/02 Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-008 3/30/99 3/31/99 3/31/99 5/18/00 Fragmin Indication: Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism, in patient undergoing hip replacement surgery. Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-018 8/3/00 8/4/00 8/4/00 Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-011 2/27/03 3/10/03 Fragmin (dalteparin sodium injection), Pharmacia and Upjohn NDA 20-287/S-010 5/25/99 6/19/00 Fragmin Indication: Treatment of unstable angina and non-Q-wave myocardial infarction for the prevention of ischemic complications in patients on concurrent aspirin therapy. Fragmin (dalteparin sodium injection), Pharmacia and Upjohn

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