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ANDA212650 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ramelteon Tablets Are Indicated For The Treatment Of Insomnia Characterized By Difficulty With Sleep Onset. The Clinical Trials Performed In Support Of Efficacy Were Up To Six Months In Duration. The Final Formal Assessments Of Sleep Latency Were Performed After Two Days Of Treatment During The Crossover Study (elderly Only), At Five Weeks In The Six Week Studies (adults And Elderly), And At The End Of The Six Month Study (adults And Elderly) [see Clinical Studies (14) ]. Ramelteon Tablets Are Indicated For The Treatment Of Insomnia Characterized By Difficulty With Sleep Onset.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ramelteon RAMELTEON ZINC3960338

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