Orange Book product
ROPINIROLE HYDROCHLORIDE EQ 5MG BASE
Orange Book ANDA 204022 · ACCORD HEALTHCARE INC · Prescription
Key facts
| Proprietary name | ROPINIROLE HYDROCHLORIDE |
|---|---|
| Active ingredients | ROPINIROLE HYDROCHLORIDE |
| Strength | EQ 5MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA204022 |
| Applicant holder | ACCORD HEALTHCARE INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 28, 2017 |
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.