Application Nr Approved Date Route Status External Links
ANDA078581 2009-09-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Temazepam Capsules 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 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 (5 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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