FdaApplication
ANDA 217862
Identifiers
- fda_app_no: ANDA217862
Properties
| Property | Value |
|---|---|
| applicant_name | ELITE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2025-11-10 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL |
5 products