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 219919 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient MIRTAZAPINE Form and strength TABLET;ORAL - 30MG Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2026-02-02 00:00:00.
Structured Monograph
Clinical summary
Approval overview MIRTAZAPINE is listed in Drugs@FDA under application 219919 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MIRTAZAPINE Form and strength TABLET;ORAL - 30MG Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2026-02-02 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.