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

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