Orange Book product
SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML
Orange Book ANDA 078053 · RANBAXY LABORATORIES LTD · Discontinued
Key facts
| Proprietary name | SERTRALINE HYDROCHLORIDE |
|---|---|
| Active ingredients | SERTRALINE HYDROCHLORIDE |
| Strength | EQ 20MG BASE/ML |
| Dosage form | CONCENTRATE |
| Route | ORAL |
| Application | ANDA078053 |
| Applicant holder | RANBAXY LABORATORIES LTD |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 5, 2007 |
At a glance
- 1–9 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.