Application Nr Approved Date Route Status External Links
ANDA084113 1982-01-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For The Management Of Manifestations Of Psychotic Disorders. For The Treatment Of Schizophrenia. To Control Nausea And Vomiting. For Relief Of Restlessness And Apprehension Before Surgery. For Acute Intermittent Porphyria. As An Adjunct In The Treatment Of Tetanus. To Control The Manifestations Of The Manic Type Of Manic-Depressive Illness. For Relief Of Intractable Hiccups. For The Treatment Of Severe Behavioral Problems In Children (1 To 12 Years Of Age) Marked By Combativeness And/or Explosive Hyperexcitable Behavior (out Of Proportion To Immediate Provocations), And In The Short-Term Treatment Of Hyperactive Children Who Show Excessive Motor Activity With Accompanying Conduct Disorders Consisting Of Some Or All Of The Following Symptoms: Impulsivity, Difficulty Sustaining Attention, Aggressivity, Mood Lability And Poor Frustration Tolerance.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Acacia ACACIA Unresolved EMUL-Emulsifier , STAB-Stabilizer FS-Substances permitted as optional ingredient in a standardized food.
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Calcium Sulfate, Unspecified Form CALCIUM SULFATE, UNSPECIFIED FORM Molecular
4. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
6. 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.
7. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
8. Shellac SHELLAC Unresolved
9. Povidones POVIDONES Unresolved
10. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
11. Sodium Benzoate SODIUM BENZOATE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Chlorpromazine Hydrochloride CHLORPROMAZINE HYDROCHLORIDE ZINC44027

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