Product manufactured by Bryant Ranch Prepack

Application Nr Approved Date Route Status External Links
ANDA077749 2006-03-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications Diazepam Tablets Are Indicated For The Management Of Anxiety Disorders Or For The Short-Term Relief Of The Symptoms Of Anxiety. Anxiety Or Tension Associated With The Stress Of Everyday Life Usually Does Not Require Treatment With An Anxiolytic. In Acute Alcohol Withdrawal, Diazepam May Be Useful In The Symptomatic Relief Of Acute Agitation, Tremor, Impending Or Acute Delirium Tremens And Hallucinosis. Diazepam Is A Useful Adjunct For The Relief Of Skeletal Muscle Spasm Due To Reflex Spasm To Local Pathology (such As Inflammation Of The Muscles Or Joints, Or Secondary To Trauma); Spasticity Caused By Upper Motor Neuron Disorders (such As Cerebral Palsy And Paraplegia); Athetosis; And Stiff-Man Syndrome. Oral Diazepam May Be Used Adjunctively In Convulsive Disorders, Although It Has Not Proved Useful As The Sole Therapy. The Effectiveness Of Diazepam In Long-Term Use, That Is, More Than 4 Months, Has Not Been Assessed By Systematic Clinical Studies. The Physician Should Periodically Reassess The Usefulness Of The Drug For The Individual Patient.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diazepam DIAZEPAM ZINC6427