NDC 64764-0805-30
ramelteon 8 mg/1 TABLET, FILM COATED
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NDC
64764-0805-30
Generic Name
ramelteon
Brand Name
Rozerem
Strength
8 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Package Size
—
Labeler
Takeda Pharmaceuticals America, Inc.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE ROZEREM ® is 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) ] . ROZEREM…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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