Application Nr Approved Date Route Status External Links
ANDA071108 1986-12-08 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Flurazepam Hydrochloride Capsules Are A Hypnotic Agent Useful For The Treatment Of Insomnia Characterized By Difficulty In Falling Asleep, Frequent Nocturnal Awakenings, And/or Early Morning Awakening. Flurazepam Hydrochloride Capsules Can Be Used Effectively In Patients With Recurring Insomnia Or Poor Sleeping Habits, And In Acute Or Chronic Medical Situations Requiring Restful Sleep. Sleep Laboratory Studies Have Objectively Determined That Flurazepam Hydrochloride Capsules Are Effective For At Least 28 Consecutive Nights Of Drug Administration. Since Insomnia Is Often Transient And Intermittent Short-Term Use Is Usually Sufficient. Prolonged Use Of Hypnotics Is Usually Not Indicated And Should Only Be Undertaken Concomitantly With Appropriate Evaluation Of The Patient.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Flurazepam Hydrochloride FLURAZEPAM HYDROCHLORIDE ZINC537752