FDA approved the original new drug application for ABILIFY MAINTENA KIT on February 28, 2013, sponsored by OTSUKA PHARM CO LTD. FDA has approved 4 efficacy supplements on the application since, the most recent on March 28, 2025.
- Application
- NDA202971
- Sponsor
- OTSUKA PHARM CO LTD
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- aripiprazole
Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| aripiprazole 400MG | FOR SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | Prescription |
| aripiprazole 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | Prescription |
| aripiprazole 300MG | FOR SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | Prescription |
| aripiprazole 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-3 | standard | |
| S-6 | standard | |
| S-10 | standard | |
| S-18 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 6 · Labeling 6. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to OTSUKA PHARM CO LTD
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