Orange Book product
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE
Orange Book ANDA 213485 · CSPC OUYI PHARMACEUTICAL CO LTD · Prescription
Key facts
| Proprietary name | PAROXETINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PAROXETINE HYDROCHLORIDE |
| Strength | EQ 12.5MG BASE |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA213485 |
| Applicant holder | CSPC OUYI PHARMACEUTICAL CO LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 16, 2021 |
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.