Orange Book product
SERTRALINE HYDROCHLORIDE EQ 50MG BASE
Orange Book ANDA 078677 · REYOUNG CORPORATION · Prescription
Key facts
| Proprietary name | SERTRALINE HYDROCHLORIDE |
|---|---|
| Active ingredients | SERTRALINE HYDROCHLORIDE |
| Strength | EQ 50MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA078677 |
| Applicant holder | REYOUNG CORPORATION |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 4, 2009 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.