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FDA NDA · NDA216352

ERZOFRI EXTENDED-RELEASE

paliperidone palmitate

Sponsor: LUYE INNOMIND PHARMA

APPLICATION
NDA216352
TYPE
NDA
ORIGINAL APPROVAL
2024-07-26
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ERZOFRI · ReferencePrescription
PALIPERIDONE PALMITATE 117MG/0.75ML (117MG/0.75ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ERZOFRI · ReferencePrescription
PALIPERIDONE PALMITATE 39MG/0.25ML (39MG/0.25ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ERZOFRI · ReferencePrescription
PALIPERIDONE PALMITATE 351MG/2.25ML (156MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ERZOFRI · ReferencePrescription
PALIPERIDONE PALMITATE 156MG/ML (156MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ERZOFRI · ReferencePrescription
PALIPERIDONE PALMITATE 78MG/0.5ML (78MG/0.5ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ERZOFRI · ReferencePrescription
PALIPERIDONE PALMITATE 234MG/1.5ML (156MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-01-22Labeling · Supplement 1 · standard — Label ↗AP
2024-07-26Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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