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Details for Generic Name: methylphenidate

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Summary for Generic Name: methylphenidate

Drug Master File Entries: see list24
Suppliers: see list1

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage

Clinical Trials for: methylphenidate

Methylphenidate Study in Breast or Gastrointestinal Cancer Patients
Status: Terminated Condition: Breast Cancer; Fatigue; Gastrointestinal Cancer

A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV
Status: Recruiting Condition: HIV Dementia

The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.
Status: Terminated Condition: Parkinson's Disease

Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Status: Completed Condition: Attention Deficit Hyperactivity Disorder; INSOMNIA

Effect of Methylphenidate on Connectivity
Status: Withdrawn Condition: Attention Deficit Hyperactivity Disorder

Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284Apr 10, 2004RXNo6,635,284<disabled>Y<disabled>
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284Jun 5, 2002RXNo7,431,944<disabled>Y<disabled>
Barr Labs Inc
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL079031Jul 13, 2012RXNo<disabled><disabled>
Janssen Pharms
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121Apr 1, 2002RXNo6,919,373*PED<disabled>Y<disabled>
Watson Labs
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL040410Feb 9, 2001DISCNNo<disabled><disabled>
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