Application Nr Approved Date Route Status External Links
ANDA071918 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Doxepin Hydrochloride Oral Solution Is Recommended For The Treatment Of: Psychoneurotic Patients With Depression And/or Anxiety. Depression And/or Anxiety Associated With Alcoholism (not To Be Taken Concomitantly With Alcohol). Depression And/or Anxiety Associated With Organic Disease (the Possibility Of Drug Interaction Should Be Considered If The Patient Is Receiving Other Drugs Concomitantly). Psychotic Depressive Disorders With Associated Anxiety Including Involutional Depression And Manic-Depressive Disorders. The Target Symptoms Of Psychoneurosis That Respond Particularly Well To Doxepin Hydrochloride Include Anxiety, Tension, Depression, Somatic Symptoms And Concerns, Sleep Disturbances, Guilt, Lack Of Energy, Fear, Apprehension And Worry. Clinical Experience Has Shown That Doxepin Hydrochloride Is Safe And Well Tolerated Even In The Elderly Patient. Owing To Lack Of Clinical Experience In The Pediatric Population, Doxepin Hydrochloride Is Not Recommended For Use In Pediatric Patients Under 12 Years Of Age.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE ZINC1331

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