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General MedicationsINTRAMUSCULARStandard

ABILIFY MAINTENA KIT

ARIPIPRAZOLE

Standard Dose
300MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ABILIFY MAINTENA KIT is listed in Drugs@FDA under application 202971 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ARIPIPRAZOLE Form and strength FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 300MG Sponsor OTSUKA PHARM CO LTD Submission history Latest submission status date: 2026-01-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview ABILIFY MAINTENA KIT is listed in Drugs@FDA under application 202971 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ARIPIPRAZOLE Form and strength FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 300MG Sponsor OTSUKA PHARM CO LTD Submission history Latest submission status date: 2026-01-28 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
ABILIFY MAINTENA KIT (ARIPIPRAZOLE) | Drug Monograph | MedicHelpline