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General MedicationsSUBCUTANEOUSStandard

UZEDY

RISPERIDONE

Standard Dose
200MG/0.56ML (200MG/0.56ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview UZEDY is listed in Drugs@FDA under application 213586 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RISPERIDONE Form and strength SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 200MG/0.56ML (200MG/0.56ML) Sponsor TEVA Submission history Latest submission status date: 2025-10-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview UZEDY is listed in Drugs@FDA under application 213586 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RISPERIDONE Form and strength SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 200MG/0.56ML (200MG/0.56ML) Sponsor TEVA Submission history Latest submission status date: 2025-10-10 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.