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General MedicationsORALStandard

CLOZAPINE

CLOZAPINE

Standard Dose
12.5MG
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Prescription
Summary

Approval overview CLOZAPINE is listed in Drugs@FDA under application 212923 (ANDA).

Marketing status: Prescription Active ingredient CLOZAPINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2025-06-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview CLOZAPINE is listed in Drugs@FDA under application 212923 (ANDA). Marketing status: Prescription Active ingredient CLOZAPINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2025-06-13 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.