Application Nr Approved Date Route Status External Links
ANDA089741 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Fluphenazine Hydrochloride Tablets Are Indicated In The Management Of Manifestations Of Psychotic Disorders. Fluphenazine Hydrochloride Has Not Been Shown Effective In The Management Of Behavioral Complications In Patients With Mental Retardation.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Calcium Phosphate, Dibasic, Dihydrate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Water WATER Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE ZINC19203912

Comments