ABILIFY MAINTENA (ARIPIPRAZOLE)
Summary
FDA approved ABILIFY MAINTENA (ARIPIPRAZOLE) by OTSUKA PHARM CO LTD. NDA (New Drug) approval (Labeling) on 2026-01-28. FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR.
Details
Source
Drug Approval
External ID
NDA202971-20
Action Date
2026-01-28
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ABILIFY MAINTENA (generic: ARIPIPRAZOLE), FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR. Application: NDA202971
Company
Context & Analysis
Frequently Asked Questions
How often does OTSUKA PHARM CO LTD have FDA actions?
This is the only FDA action we have on record for OTSUKA PHARM CO LTD in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA202971-20" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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