Orange Book product
PAXIL CR EQ 12.5MG BASE
Orange Book NDA 020936 · APOTEX INC · Prescription
Key facts
| Proprietary name | PAXIL CR |
|---|---|
| Active ingredients | PAROXETINE HYDROCHLORIDE |
| Strength | EQ 12.5MG BASE |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | NDA020936 |
| Applicant holder | APOTEX INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Feb 16, 1999 |
At a glance
- 1–9 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.