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FDA NDA · NDA207946

INVEGA HAFYERA

paliperidone palmitate

Sponsor: JANSSEN PHARMS

APPLICATION
NDA207946
TYPE
NDA
ORIGINAL APPROVAL
2015-05-18
LATEST ACTION
2025-01-23
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

INVEGA HAFYERA · ReferencePrescription
PALIPERIDONE PALMITATE 1.560GM/5ML (312MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
INVEGA TRINZA · ReferencePrescription
PALIPERIDONE PALMITATE 819MG/2.625ML (312MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
INVEGA TRINZA · ReferencePrescription
PALIPERIDONE PALMITATE 410MG/1.315ML (311.79MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
INVEGA HAFYERA · ReferencePrescription
PALIPERIDONE PALMITATE 1.092GM/3.5ML (312MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
INVEGA TRINZA · ReferencePrescription
PALIPERIDONE PALMITATE 546MG/1.75ML (312MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
INVEGA TRINZA · ReferencePrescription
PALIPERIDONE PALMITATE 273MG/0.875ML (273MG/0.875ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-01-23Labeling · Supplement 17 · standard — Label ↗AP
2024-09-12Labeling · Supplement 14 · standard — Letter ↗AP
2024-09-12Labeling · Supplement 15 · standard — Letter ↗AP
2021-08-30Efficacy · Supplement 10 · standard — Letter ↗AP
2021-08-09Labeling · Supplement 11 · standard — Letter ↗AP
2021-02-12Labeling · Supplement 9 · standard — Letter ↗AP
2019-01-25Labeling · Supplement 8 · standard — Label ↗AP
2018-07-27Labeling · Supplement 6 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 3 · 901 required — Label ↗AP
2016-03-01Labeling · Supplement 1 · standard — Label ↗AP
2015-05-18Type 5 - New Formulation or New Manufacturer · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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