Orange Book product
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE
Orange Book ANDA 209293 · SCIECURE PHARMA INC · Prescription
Key facts
| Proprietary name | PAROXETINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PAROXETINE HYDROCHLORIDE |
| Strength | EQ 12.5MG BASE |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA209293 |
| Applicant holder | SCIECURE PHARMA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 12, 2018 |
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.