Orange Book product
REMERON SOLTAB 30MG
Orange Book NDA 021208 · ORGANON USA LLC A SUB OF ORGANON AND CO · Prescription
Key facts
| Proprietary name | REMERON SOLTAB |
|---|---|
| Active ingredients | MIRTAZAPINE |
| Strength | 30MG |
| Dosage form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Application | NDA021208 |
| Applicant holder | ORGANON USA LLC A SUB OF ORGANON AND CO |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jan 12, 2001 |
At a glance
- 1–9 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.