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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 | Risperidone Oral Solution, Apotex Inc., Tentative Approval | Risperidone, Tablets, Cobalt Laboratories, Inc., Approval | Risperidone Tablets, Vintage Pharmaceuticals, LLC, Approval | Risperidone Oral Solution, Teva Pharmaceuticals USA, Approval | Risperidone Oral Solution, Roxane Laboratories, Inc., Tentative Approval | Risperidone Oral Solution, Dr. Reddy's Laboratories Ltd., Tentative Approval | Risperidone Tablets, Cadista Pharmaceuticals Inc., Approval | Risperidone Orally Disintegrating Tablets, Zydus Pharmaceuticals USA Inc., Approval | Risperidone Orally Disintegrating Tablets, Kali Laboratories, Inc., Approval | Risperdal CONSTA (risperidone) Intramuscular Injection, Johnson & Johnson Pharmaceutical, New or Modified Indication | Risperidone Tablets, Hikma Pharmaceuticals, Approval | Risperidone Tablets USP, Actavis Totowa LLC, Approval | Risperdal (risperidone) Tablets, Johnson & Johnson Pharmaceutical R & D, L.L.C., Labeling Revision | Risperdal (risperidone) Oral Solution, Johnson & Johnson Pharmaceutical R & D, L.L.C., Labeling Revision | Risperdal Consta (risperidone) Long-Acting Injection, Johnson & Johnson Pharmaceutical R & D, L.L.C., Labeling Revision | Risperdal (risperidone) Orally Disintegrating Tablets, Johnson & Johnson Pharmaceutical R & D, L.L.C., Labeling Revision | Risperidone Oral Solution, Roxane Laboratories, Inc., Approval | Risperidone Oral Solution, Dr. Reddy's Laboratories Ltd., Approval | Risperidone Oral Solution, Apotex Inc., Approval | Risperidone Oral Solution, Aurobindo Pharma Limited, Approval | Risperidone Orally Disintegrating Tablet, Dr. Reddy's Laboratories Ltd., Supplement | Risperidone Oral Solution, Wockhardt Ltd., Approval | Risperidone Tablets, Sandoz, Inc., Approval | Risperidone Tablets, Synthon Pharmaceuticals, Inc., Approval | Risperidone Orally Disintegrating Tablets, Par Pharmaceutical, Inc., New Strength | Risperidone Orally Disintegrating Tablets, Dr. Reddy’s Laboratories Ltd., Chemistry New Strength | Risperidone Orally Disintegrating Tablets, Sandoz Inc., Approval | Risperidone Orally Disintegrating Tablets, Ratiopharm, Approval | Risperidone Oral Solution, Precision Dose, Inc., Approval | Risperidone Orally Disintegrating Tablets, Ranbaxy Laboratories Limited, Approval | Risperdal (risperidone) Tablets, Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision | Risperdal (risperidone) Oral Solution, Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision | Risperdal Consta (risperidone) Intramuscular Injection, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal (risperidone) Oral Disintegrating Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision | Risperidone Oral Solution, Taro Pharmaceuticals U.S.A., Inc., Approval | Risperidone Orally-Disintegrating Tablets, Mylan Pharmaceuticals, Inc., Approval | Risperidone Orally-Disintegrating Tablets, Watson Laboratories, Inc., Approval | Risperidone Oral Solution, Amneal Pharmaceuticals, Approval | Risperdal (risperidone) Tablets, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal (risperidone) Oral Solution, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal Consta (risperidone) Intramuscular Injection, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal (risperidone) Orally Disintegrating Tablets, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperidone Tablets, Ajanta Pharma, Ltd., Approval | Risperdal (risperidone) Tablets, Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal (risperidone) Oral Solution, Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal (risperidone) Orally Disintegrating Tablets, Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal Consta (risperidone) Intramuscular Injection, Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal (risperidone) Tablets, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal Oral Solution, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal Orally Disintegrating Tablets, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperdal Consta (risperidone) Intramuscular Injection, Ortho McNeil Janssen Pharmaceuticals, Inc., Labeling Revision | Risperidone Orally Disintegrating Tablets, Jubilant Life Sciences, Ltd., Approval | Risperidone Tablets, Prinston Pharmaceuticals Inc., Approval | Risperdal Consta (risperidone) Intramuscular Injection, Janssen Pharmaceuticals, Inc., Labeling Revision
  
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