eszopiclone tablet film coated
1 INDICATIONS AND USAGE Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance ( 1 ).
glenmark pharmaceuticals inc. usa
ROUND WHITE G 383
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glenmark pharmaceuticals inc. usa
eszopiclone tablet film coated
glenmark pharmaceuticals inc. usa
eszopiclone tablet film coated
glenmark pharmaceuticals inc. usa
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16 HOW SUPPLIED/STORAGE AND HANDLING
ESZOPICLONE Tablets, USP, 3 mg are round, dark blue, film-coated, and identified with debossed markings of ‘384’ on one side, and ‘G’ on the other side and are supplied as: NDC 68462-384-30 bottle of 30 tablets NDC 68462-384-01 bottle of 100 tablets NDC 68462-384-10 bottle of 1000 tablets
ESZOPICLONE Tablets, USP, 2 mg are round, white to off-white, film-coated, and identified with debossed markings of ‘383’ on one side, and ‘G’ on the other side and are supplied as: NDC 68462-383-01 bottle of 100 tablets NDC 68462-383-10 bottle of 1000 tablets
ESZOPICLONE Tablets, USP, 1 mg are round, light blue, film-coated, and identified with debossed markings of ‘382’ on one side, and ‘G’ on the other side and are supplied as: NDC 68462-382-30 bottle of 30 tablets NDC 68462-382-01 bottle of 100 tablets NDC 68462-382-10 bottle of 1000 tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°F to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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