Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.