NDC 52817-0235-30
Ramelteon 8 mg/1 TABLET, FILM COATED
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NDC
52817-0235-30
Generic Name
Ramelteon
Brand Name
Ramelteon
Strength
8 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Package Size
—
Labeler
TruPharma, LLC
FDA Drug Information
Indications & Usage
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) ].…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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