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Tradename: INTERMEZZO
Summary for Tradename: INTERMEZZO
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Clinical Trials for: INTERMEZZOFed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets Status: Completed Condition: Healthy; Therapeutic Equivalency Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions Status: Completed Condition: Healthy Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia Status: Completed Condition: Chronic Insomnia A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients Status: Completed Condition: Sleep Initiation and Maintenance Disorders; Primary Insomnia Zolpidem CR and Hospitalized Patients With Dementia Status: Recruiting Condition: Dementia; Alzheimer Disease; Dementia, Vascular; Sleep Disorders; Circadian Dysregulation A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia Status: Completed Condition: Insomnia Use of Zolpidem in Parkinson's Disease Status: Withdrawn Condition: Parkinson's Disease Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia. Status: Completed Condition: Sleep Initiation and Maintenance Disorders Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet Status: Completed Condition: Insomnia Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing Status: Completed Condition: Insomnia; Primary Insomnia; Psychophysiologic Insomnia Courtesy of ClinicalTrials.org See more clinical trials for this drug | ||||||||||||
Glossary
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Product | Substance | Delist_Flag | Patent Expiration | Exclusivity Expiration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Transcept Pharms | INTERMEZZO | zolpidem tartrate | TABLET; SUBLINGUAL | 022328 | Nov 23, 2011 | RX | No | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Transcept Pharms | INTERMEZZO | zolpidem tartrate | TABLET; SUBLINGUAL | 022328 | Nov 23, 2011 | RX | No | 7,658,945 | Y | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Transcept Pharms | INTERMEZZO | zolpidem tartrate | TABLET; SUBLINGUAL | 022328 | Nov 23, 2011 | RX | No | 7,682,628 | <disabled> | <disabled> | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Transcept Pharms | INTERMEZZO | zolpidem tartrate | TABLET; SUBLINGUAL | 022328 | Nov 23, 2011 | RX | Yes | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Paragraph IV activity for: INTERMEZZO
| Drugname | Dosage | Strength | RLD | Submissiondate |
| zolpidem tartrate | Sublingual Tablets | 1.75 mg and 3.5 mg | Intermezzo | 4/10/2012 |
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