Source facts
FDA issued an approval letter for ABILIFY MAINTENA KIT on 2026-01-29. The source metadata identifies NDA 202971 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ABILIFY MAINTENA KIT — FDA Approval Letter (NDA 202971)
Issued to OTSUKA PHARM CO LTD. Application is approved as submitted.
Issued
January 29, 2026Application
NDA 505b1 • 202971
Product
ABILIFY MAINTENA KIT
Company
OTSUKA PHARM CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ABILIFY MAINTENA KIT?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 202971.
- 3Submission: supplement.
- 4Sponsor: OTSUKA PHARM CO LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ABILIFY MAINTENA KIT approval letter
Is ABILIFY MAINTENA KIT FDA approved?
This letter documents an FDA approval action: FDA approved NDA 202971 for ABILIFY MAINTENA KIT, sponsored by OTSUKA PHARM CO LTD, on January 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 202971?
NDA 202971 is the application under which FDA issued this approval letter for ABILIFY MAINTENA KIT to OTSUKA PHARM CO LTD. The letter is dated January 29, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.