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 Drug Recalls 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… Risperdal (risperidone) oral solution & orally disintegrating Johnson & Johnson Pharmaceutical Research & Development, 20-272/S33, 20-588/21 & 21-444/S4 9/10/03 9/25/03 Risperdal (risperidone) orally disintegrating Johnson & Johnson Pharmaceutical Research & Development, 21-444 4/2/03 7/15/03 Risperdal (risperidone) & Solution, Johnson & Johnson Pharmaceutical Research & Development, 20-588/ SE5-015 & 20-272/ SE5-024 11/19/02 11/22/02 Risperdal (risperidone) Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 20-588/ SE5-004 & 20-272/ SE5-008 3/3/02 3/12/02 Risperdal (risperidone) Janssen 20-588/ SE5-005 & 20-272/ SE5-009 7/2/99 7/2/99 7/2/99 Rezulin Indication: Change in labeling to expand Geriatric Use Risperdal (risperidone) Johnson & Johnson Risperdal Consta (risperidone) Johnson & Johnson RISPERIDONE Solution; RISPERDAL JANSSEN 021444 RISPERIDONE RISPERDAL JOHNSON AND JOHNSON 021444 RISPERIDONE RISPERDAL JOHNSON AND JOHNSON 021444 RISPERIDONE RISPERDAL JOHNSON AND JOHNSON 020272 RISPERIDONE 0.2 RISPERDAL JANSSEN 020272 RISPERIDONE RISPERDAL JANSSEN 020272 RISPERIDONE RISPERDAL JANSSEN 020272 RISPERIDONE RISPERDAL JANSSEN 020272 RISPERIDONE RISPERDAL JANSSEN 020272 RISPERIDONE RISPERDAL JANSSEN Risperdal (risperidone) M-TAB Orally Disintegrating, Janssen Risperdal (risperidone) Johnson & Johnson Risperidone Tablets, Mylan Pharmaceuticals | RISPERDAL M-TAB (risperidone) Orally Disintegrating Tablets, Johnson & Johnson, Formulation Revision | Risperidone Oral Solution, Roxane Labs, Tentative Approval | Risperdal (risperidone) Tablets, Johnson & Johnson, Labeling Revision | Risperdal (risperidone) Oral Solution, Johnson & Johnson, Labeling Revision | Risperdal M-Tab Orally Disintegrating Tablets, Johnson & Johnson, Labeling Revision | Risperdal Consta Injection, Johnson & Johnson, Labeling Revision | Risperidone Oral Solution, Par Pharma, Tentative Approval | Risperidone Oral Solution, Ranbaxy Labs, Tentative Approval | Risperdal Consta (Risperidone) Long-Acting Injection, Johnson & Johnson, Labeling Revision | Risperdal Consta (risperidone) Long-Acting Injection, Johnson & Johnson, Labeling Revsion | Risperdal (risperidone) Tablets, Johnson & Johnson, New or Modified Indication | Risperdal (risperidone) Oral Solution, Johnson & Johnson, New or Modified Indication | Risperdal (risperidone) M-TAB, Johnson & Johnson, New or Modified Indication | Risperidone Oral Solution, Teva Pharma, Tentative Approval | Risperdal Consta (risperidone) Long Acting Injection, Johnson & Johnson, Labeling Revision | Risperdal (risperidone) Consta Long Acting Injection, Johnson & Johnson, Labeling Revision | Risperdal Consta (risperidone) Injection, Janssen Pharma, New Dosage Regimen | Risperidone Tablets, Pliva Hrvatska, Tentative Approval | Risperdal (risperidone) Tablets, Janssen Pharma, Patient Population Altered | Risperdal (risperidone) Oral Solution, Janssen Pharma, Patient Population Altered | Risperdal M-Tab (risperidone) Orally Disintegrating Tablets, Janssen Pharma, Patient Population Altered | Risperidone Oral Solution, Par Pharma, Tentative Approval | Risperidone Tablets, Ranbaxy, Approval | Risperidone Tablets, TEVA Pharmaceuticals USA, Approval | Risperdal (risperidone) Oral Solution, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Risperdal (risperidone) Orally Disintegrating Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Risperdal (risperidone) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Risperdal Consta (risperidone) Intramuscular Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Risperidone Tablets, Apotex Corp., Approval | Risperidone Tablets, Mylan Pharmaceuticals, Inc., Approval | Risperdal Consta (risperidone) Intramuscular Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision | Risperidone Tablets, Aurobindo Pharma Ltd., Approval | Risperidone Tablets, Wockhardt Ltd., Approval| Risperidone Tablets, Dr. Reddy’s Laboratories Ltd., Approval | Risperidone Tablets, Torrent Pharmaceuticals Limited, Approval ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com