Application Nr Approved Date Route Status External Links
NDA022264 2009-07-31 Intramuscular RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Invega Sustenna® (paliperidone Palmitate) Is Indicated For The Treatment Of: Schizophrenia [see Clinical Studies (14.1)]. Schizoaffective Disorder As Monotherapy And As An Adjunct To Mood Stabilizers Or Antidepressants [see Clinical Studies (14.2)]. Invega Sustenna® Is An Atypical Antipsychotic Indicated For Treatment Of Schizophrenia. (1) Treatment Of Schizoaffective Disorder As Monotherapy And As An Adjunct To Mood Stabilizers Or Antidepressants. (1)

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Sodium Phosphate, Monobasic, Anhydrous SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS Molecular
2. Sodium Phosphate, Monobasic, Monohydrate SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE Molecular
3. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Paliperidone Palmitate PALIPERIDONE PALMITATE ZINC1481956

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