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Sparlon FDA Approval Status

FDA Approved: No
Brand name: Sparlon
Generic name: modafinil
Dosage form: Tablets
Previous Name: Attenace
Company: Cephalon, Inc.
Treatment for: ADHD in Children and Adolescents

Development timeline for Sparlon

Aug  9, 2006Cephalon Receives Non-Approvable Letter on Sparlon
Mar 23, 2006FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents
Jan 25, 2006Cephalon, Inc. Provides Update on Regulatory Status of Sparlon
Oct 21, 2005Cephalon Receives Approvable Letter for Sparlon for the Treatment of ADHD in Children and Adolescents
Dec 21, 2004Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

Further information

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