RYKINDO EXTENDED-RELEASE MICROSPHERES (RISPERIDONE)
Summary
FDA approved RYKINDO EXTENDED-RELEASE MICROSPHERES (RISPERIDONE) by SHANDONG LUYE. NDA (New Drug) approval (Labeling) on 2026-01-16. FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR.
Details
Source
Drug Approval
External ID
NDA212849-3
Action Date
2026-01-16
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
RYKINDO EXTENDED-RELEASE MICROSPHERES (generic: RISPERIDONE), FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR. Application: NDA212849
Company
Context & Analysis
Frequently Asked Questions
How often does SHANDONG LUYE have FDA actions?
This is the only FDA action we have on record for SHANDONG LUYE in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA212849-3" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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