paliperidone palmitate
paliperidone palmitate is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including Erzofri extended-release, INVEGA TRINZA, INVEGA SUSTENNA. Available dosage forms: injection, injection, suspension, extended release.
Drug Details
- Generic Name
- paliperidone palmitate
- Brand Names
- Erzofri extended-release, INVEGA TRINZA, INVEGA SUSTENNA, INVEGA HAFYERA
- Application Number
- NDA216352
- Sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- NDC Codes
- 17
- Dosage Forms
- INJECTION, INJECTION, SUSPENSION, EXTENDED RELEASE
- Routes
- INTRAMUSCULAR
- Active Ingredients
- PALIPERIDONE PALMITATE
Indications and Usage
1 INDICATIONS AND USAGE INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults [see Clinical Studies (14.1) ]. Schizoaffective disorder in adults 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 in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. ( 1 )