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General MedicationsINTRAMUSCULARStandard

ARISTADA INITIO KIT

ARIPIPRAZOLE LAUROXIL

Standard Dose
675MG/2.4ML (281.25MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ARISTADA INITIO KIT is listed in Drugs@FDA under application 209830 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ARIPIPRAZOLE LAUROXIL Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 675MG/2.4ML (281.25MG/ML) Sponsor ALKERMES INC Submission history Latest submission status date: 2025-01-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview ARISTADA INITIO KIT is listed in Drugs@FDA under application 209830 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ARIPIPRAZOLE LAUROXIL Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 675MG/2.4ML (281.25MG/ML) Sponsor ALKERMES INC Submission history Latest submission status date: 2025-01-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.