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… Integrilin (eptifibatide) Injection, 20 mg/10 ml and 75 mg/ 100 ml, Injection, COR Therapeutics NDA 20-718 5/18 5/28/98 5/28/98 1/2/02 | Integrilin Indications: 1. For the treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction. 2. For the treatment of patients undergoing PCI. In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpont of death, new myocardial infarction, or need for urgent intervention. Integrilin (eptifibatide) Injection, COR Therapeutics, NDA 20-718/S-002 9/20/99 9/24/99 9/24/99 7/5/01 | Integrilin Indication:For the treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, Integrilin has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction. | For the treatment of patients undergoing PCI. In this setting, Integrilin has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention. | Integrilin (eptifibatide) Injection, COR Therapeutics, NDA 20-718/S-010 & S-13 EPTIFIBATIDE Injection 2MG/ML INTEGRILIN MILLENNIUM | 020718 EPTIFIBATIDE Injection 75MG/100ML INTEGRILIN MILLENNIUM Integrilin (eptifibatide) Injection, Millennium Pharmaceuticals, Inc., Labeling Revision | Integrilin (eptifibatide) Injection, Millennium Pharma, Labeling Revision | Integrilin (eptifibatide) Injection, Schering Corp., Labeling Revision | Integrilin (eptifibatide) Injection, Schering-Plough, 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