U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 216352
Company: LUYE INNOMIND PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERZOFRI PALIPERIDONE PALMITATE 39MG/0.25ML (39MG/0.25ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes
ERZOFRI PALIPERIDONE PALMITATE 78MG/0.5ML (78MG/0.5ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes
ERZOFRI PALIPERIDONE PALMITATE 117MG/0.75ML (117MG/0.75ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes
ERZOFRI PALIPERIDONE PALMITATE 156MG/ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes
ERZOFRI PALIPERIDONE PALMITATE 234MG/1.5ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes
ERZOFRI PALIPERIDONE PALMITATE 351MG/2.25ML (156MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/26/2024 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216352s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216352Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216352Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2025 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216352s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216352Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/22/2025 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216352s001lbl.pdf
07/26/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216352s000lbl.pdf
Back to Top