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General MedicationsORALStandard

MIRTAZAPINE

MIRTAZAPINE

Standard Dose
30MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MIRTAZAPINE is listed in Drugs@FDA under application 205798 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MIRTAZAPINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 30MG Sponsor SQUARE PHARMS PLC Submission history Latest submission status date: 2023-12-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview MIRTAZAPINE is listed in Drugs@FDA under application 205798 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MIRTAZAPINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 30MG Sponsor SQUARE PHARMS PLC Submission history Latest submission status date: 2023-12-06 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.