Application Nr Approved Date Route Status External Links
ANDA201781 2015-06-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Temazepam Capsules Usp Are Indicated For The Short-Term Treatment Of Insomnia (generally 7 To 10 Days). For Patients With Short-Term Insomnia, Instructions In The Prescription Should Indicate That Temazepam Capsules Usp Should Be Used For Short Periods Of Time (7 To 10 Days). The Clinical Trials Performed In Support Of Efficacy Were 2 Weeks In Duration With The Final Formal Assessment Of Sleep Latency Performed At The End Of Treatment.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Edetate Disodium EDETATE DISODIUM Molecular
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Temazepam TEMAZEPAM ZINC896634

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