Orange Book product
REMERON 45MG **Federal Register determination that product was not…
Orange Book NDA 020415 · ORGANON USA LLC · Discontinued
Key facts
| Proprietary name | REMERON |
|---|---|
| Active ingredients | MIRTAZAPINE |
| Strength | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA020415 |
| Applicant holder | ORGANON USA LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Mar 17, 1997 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.