Application Nr Approved Date Route Status External Links
ANDA071669 1987-11-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Doxepin Hcl 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 Hcl Include Anxiety, Tension, Depression, Somatic Symptoms And Concerns, Sleep Disturbances, Guilt, Lack Of Energy, Fear, Apprehension And Worry. Clinical Experience Has Shown That Doxepin Hcl Is Safe And Well Tolerated Even In The Elderly Patient. Owing To Lack Of Clinical Experience In The Pediatric Population, Doxepin Hcl Is Not Recommended For Use In Children Under 12 Years Of Age.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Gelatin GELATIN Unresolved
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. Shellac SHELLAC 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.
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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