Application Nr Approved Date Route Status External Links
ANDA085785 1996-10-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For The Management Of Schizophrenia. Trifluoperazine Hcl Is Effective For The Short-Term Treatment Of Generalized Non-Psychotic Anxiety. However, Trifluoperazine Hcl Is Not The First Drug To Be Used In Therapy For Most Patients With Non-Psychotic Anxiety Because Certain Risks Associated With Its Use Are Not Shared By Common Alternative Treatments (i.e., Benzodiazepines). When Used In The Treatment Of Non-Psychotic Anxiety, Trifluoperazine Hcl Should Not Be Administered At Doses Of More Than 6 Mg Per Day Or For Longer Than 12 Weeks Because The Use Of Trifluoperazine Hcl At Higher Doses Or For Longer Intervals May Cause Persistent Tardive Dyskinesia That May Prove Irreversible (see Warnings ). The Effectiveness Of Trifluoperazine Hcl As A Treatment For Non-Psychotic Anxiety Was Established In A Four-Week Clinical Multicenter Study Of Outpatients With Generalized Anxiety Disorder (dsm-Iii). This Evidence Does Not Predict That Trifluoperazine Hcl Will Be Useful In Patients With Other Non-Psychotic Conditions In Which Anxiety, Or Signs That Mimic Anxiety, Are Found (i.e., Physical Illness, Organic Mental Conditions, Agitated Depression, Character Pathologies, Etc.). Trifluoperazine Hcl Has Not Been Shown Effective In The Management Of Behavioral Complications In Patients With Mental Retardation.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. 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.
3. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
4. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE ZINC19418959