Orange Book product
ZOLOFT EQ 50MG BASE
Orange Book NDA 019839 · VIATRIS SPECIALTY LLC · Prescription
Key facts
| Proprietary name | ZOLOFT |
|---|---|
| Active ingredients | SERTRALINE HYDROCHLORIDE |
| Strength | EQ 50MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA019839 |
| Applicant holder | VIATRIS SPECIALTY LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Dec 30, 1991 |
At a glance
- 10–99 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.