Drug application
ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)
Drugs@FDA ANDA 217862 · ELITE LABS INC
Key facts
| Drug name | ROPINIROLE HYDROCHLORIDE |
|---|---|
| Active ingredients | ROPINIROLE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 217862 |
| Company | ELITE LABS INC |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | EQ 2MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Nov 10, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.