FdaApplication
ANDA 077460
Identifiers
- fda_app_no: ANDA077460
Properties
| Property | Value |
|---|---|
| applicant_name | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| application_type | ANDA |
| approval_date | 2008-05-05 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL |
7 products