Drug application
MIRTAZAPINE (MIRTAZAPINE)
Drugs@FDA ANDA 219919 · NOVITIUM PHARMA
Key facts
| Drug name | MIRTAZAPINE |
|---|---|
| Active ingredients | MIRTAZAPINE |
| Application type | ANDA |
| Application number | 219919 |
| Company | NOVITIUM PHARMA |
| Dosage forms | TABLET, ORAL |
| Strength | 7.5MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Feb 2, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.