Orange Book product
PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML
Orange Book ANDA 215003 · NOVITIUM PHARMA LLC · Prescription
Key facts
| Proprietary name | PAROXETINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PAROXETINE HYDROCHLORIDE |
| Strength | EQ 10MG BASE/5ML |
| Dosage form | SUSPENSION |
| Route | ORAL |
| Application | ANDA215003 |
| Applicant holder | NOVITIUM PHARMA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Sep 3, 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.