RISPERIDONE | N021444 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sheller, P.C. Law Offices FDA-2012-P-0857 · 9 docket documents Law offices Sheller, P.C., representing individuals harmed by Risperdal (risperidone), filed a citizen petition with the FDA pursuant to 21 U.S.C. sections 352 and 321 and 21 C.F.R. sections 10.30 and 7.45 requesting that the FDA revoke the pediatric indication for Risperdal and all generic versions | Other | 2012-08-14 | Partially Denied | Sheller, P.C. Law Offices |
Johnson & Johnson Pharmaceutical Research, LLC., (Ropes & Gray, LLP) - Citize... FDA-2011-P-0086 · 9 docket documents Johnson & Johnson Pharmaceutical Research & Development, LLC filed this citizen petition requesting that the FDA adopt specific bioequivalence parameters for evaluating proposed follow-on products under Section 505(j) ANDA or Section 505(b)(2) applications where Risperdal Consta (risperidone long-ac | 505(q) | 2011-02-23 | Denied | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0070 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Janssen Pharma's Risperdal M Tab (risperidone) orally disintegrating tablets at 3 mg and 4 mg strengths (NDA No. 21-444) were voluntarily withdrawn from sale for safety or effectiveness reasons, as the pr | Other | 2009-04-23 | Withdrawn | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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