Application Nr Approved Date Route Status External Links
ANDA071427 1988-01-12 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 (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
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.

Active Ingredients ( 1 Total)

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

Comments