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): 212849
Company: SHANDONG LUYE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYKINDO RISPERIDONE 12.5MG FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None Yes No
RYKINDO RISPERIDONE 25MG FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes Yes
RYKINDO RISPERIDONE 37.5MG FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None Yes No
RYKINDO RISPERIDONE 50MG FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/13/2023 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212849s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212849Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/212849Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2026 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212849s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212849Orig1s003Correctedltr.pdf
01/22/2025 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212849s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212849Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/16/2026 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212849s003lbl.pdf
01/22/2025 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212849s001lbl.pdf
01/13/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212849s000lbl.pdf
Back to Top