Application Nr Approved Date Route Status External Links
ANDA071523 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Trazodone Hydrochloride Tablets Usp Are Indicated For The Treatment Of Depression. The Efficacy Of Trazodone Hydrochloride Tablets Usp Has Been Demonstrated In Both Inpatient And Outpatient Settings And For Depressed Patients With And Without Prominent Anxiety. The Depressive Illness Of Patients Studied Corresponds To The Major Depressive Episode Criteria Of The American Psychiatric Association’s Diagnostic And Statistical Manual, Lll. A Major Depressive Episode Implies A Prominent And Relatively Persistent (nearly Every Day For At Least 2 Weeks) Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning, And Includes At Least Four Of The Following Eight Symptoms: Change In Appetite, Change In Sleep, Psychomotor Agitation Or Retardation, Loss Of Interest In Usual Activities Or Decrease In Sexual Drive, Increased Fatigability, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, And Suicidal Ideation Or Attempts.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE ZINC538483

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