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Details for Generic Name: eszopiclone

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Summary for Generic Name: eszopiclone

Drug Master File Entries: see list20
Suppliers: see list11
Therapeutic Class:Sedatives/Hypnotics

Clinical Trials for: eszopiclone

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Status: Completed Condition: Post-Traumatic Stress Disorders

The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
Status: Completed Condition: Depression; Anxiety; Insomnia

Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
Status: Completed Condition: Parkinson's Disease; Insomnia

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Status: Completed Condition: Insomnia; Attention Deficit Hyperactivity Disorder

Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Status: Recruiting Condition: Posttraumatic Stress Disorders

Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Status: Completed Condition: Schizophrenia

Effects of Daytime Eszopiclone Administration in Shift Workers
Status: Completed Condition: Shift-Work Sleep Disorder

Eszopiclone in the Treatment of Insomnia and Fibromyalgia
Status: Completed Condition: Fibromyalgia; Insomnia

Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome
Status: Recruiting Condition: Acute Coronary Syndrome; Sleep Disorder

Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia
Status: Completed Condition: Primary Insomnia

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc
TABLET;ORAL021476Dec 15, 2004RXNo6,444,673*PED<disabled>Y<disabled>
Orchid Hlthcare
TABLET;ORAL091113Jun 10, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
TABLET;ORAL091151Mar 26, 2013RXNo<disabled><disabled>
Sunovion Pharms Inc
TABLET;ORAL021476Dec 15, 2004RXNo<disabled><disabled>
Sunovion Pharms Inc
TABLET;ORAL021476Dec 15, 2004RXYes6,444,673*PED<disabled>Y<disabled>
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