RISPERDAL

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

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

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M Tab (risperidone) orally disintegrating tablets at 3 mg and 4 mg strengths (NDA No. 21-444) were voluntarily withdrawn from sale for safety or effectiveness reasons, as the pr

FDA-2006-P-0203 · 7 docket documents

Mylan Pharmaceuticals Inc. filed this citizen petition requesting that FDA award Mylan 180-day generic marketing exclusivity for its ANDA for risperidone tablets in six strengths (0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg), arguing that exclusivity eligibility should be determined by the date notice of

FDA-2007-P-0170 · 9 docket documents

Teva Pharmaceuticals USA filed this August 2007 citizen petition under section 505 of the Food, Drug, and Cosmetic Act requesting that FDA relist U.S. Patent No. 5,158,952 in the Orange Book for risperidone tablets under NDA No. 20-272, confirm that Teva's 180-day exclusivity for ANDA No. 76-228 rem