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Medicines · US (FDA)
Antipsychotics

FDA 2025

Other antipsychotics

Paliperidone Palmitate

Approved 16 May 2025Suspension, Extended releaseInjectable

The FDA lists this product in 16 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: PALIPERIDONE PALMITATE 156MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

PALIPERIDONE PALMITATE 39MG · InjectableANDA216674-005 · Tentative approval
PALIPERIDONE PALMITATE 117MG · InjectableANDA216674-003 · Tentative approval
PALIPERIDONE PALMITATE 78MG · InjectableANDA216674-004 · Tentative approval
PALIPERIDONE PALMITATE 156MG · InjectableThis page
PALIPERIDONE PALMITATE · SuspensionANDA210397-001 · Tentative approval
PALIPERIDONE PALMITATE 1560MG/5.0ML · InjectionANDA215682-006 · Tentative approval
PALIPERIDONE PALMITATE 819MG/2.625ML · InjectionANDA215682-004 · Tentative approval
PALIPERIDONE PALMITATE 410MG/1.315ML · InjectionANDA215682-002 · Tentative approval
PALIPERIDONE PALMITATE 1092MG/3.5ML · InjectionANDA215682-005 · Tentative approval
PALIPERIDONE PALMITATE 546MG/1.75ML · Injection

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Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA215682-003 · Tentative approval

PALIPERIDONE PALMITATE 234MG/1.5ML · Suspension, extended releaseANDA211995-005 · Tentative approval

PALIPERIDONE PALMITATE 117MG/0.75ML · Suspension, extended releaseANDA211995-003 · Tentative approval

PALIPERIDONE PALMITATE 39MG/0.25ML · Suspension, extended releaseANDA211995-001 · Tentative approval

PALIPERIDONE PALMITATE 156MG/ML · Suspension, extended releaseANDA211995-004 · Tentative approval

PALIPERIDONE PALMITATE 78MG/0.5ML · Suspension, extended releaseANDA211995-002 · Tentative approval

PALIPERIDONE PALMITATE 273MG/0.88ML · Suspension, extended releaseANDA216228-001 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA216674.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Paliperidone Palmitate
Drug class: Other antipsychotics
Group: Antipsychotics
Route: Suspension, Extended release
Dosage form: Injectable
Applicant: Accord Hlthcare Inc
Status: Tentative approval
FDA approval: 16 May 2025
Application: ANDA216674-002
RxCUI: 858045

Guidelines

Guidelines in psychiatry293 guidelines in the library

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