Application Nr Approved Date Route Status External Links
ANDA071443 1988-11-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Perphenazine And Amitriptyline Hydrochloride Tablets Are Recommended For Treatment Of (1) Patients With Moderate To Severe Anxiety And/or Agitation And Depressed Mood, (2) Patients With Depression In Whom Anxiety And/or Agitation Are Severe, And (3) Patients With Depression And Anxiety In Association With Chronic Physical Disease. In Many Of These Patients, Anxiety Masks The Depressive State So That, Although Therapy With A Tranquilizer Appears To Be Indicated, The Administration Of A Tranquilizer Alone Will Not Be Adequate. Schizophrenic Patients Who Have Associated Depressive Symptoms Should Be Considered For Therapy With Perphenazine And Amitriptyline Hydrochloride Tablets.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 2 Total)