Application Nr Approved Date Route Status External Links
ANDA201507 2013-06-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications For Symptomatic Relief Of Anxiety And Tension Associated With Psychoneurosis And As An Adjunct In Organic Disease States In Which Anxiety Is Manifested. Useful In The Management Of Pruritus Due To Allergic Conditions Such As Chronic Urticaria And Atopic And Contact Dermatoses, And In Histamine-Mediated Pruritus. As A Sedative When Used As Premedication And Following General Anesthesia, Hydroxyzine May Potentiate Meperidine (demerolĀ®) And Barbiturates, So Their Use In Pre-Anesthetic Adjunctive Therapy Should Be Modified On An Individual Basis. Atropine And Other Belladonna Alkaloids Are Not Affected By The Drug. Hydroxyzine Is Not Known To Interfere With The Action Of Digitalis In Any Way And It May Be Used Concurrently With This Agent. The Effectiveness Of Hydroxyzine As An Antianxiety Agent For Long-Term Use, That Is, More Than 4 Months, Has Not Been Assessed By Systematic Clinical Studies. The Physician Should Reassess Periodically The Usefulness Of The Drug For The Individual Patient.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydroxyzine Pamoate