Application 079229
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 0.25MG BASE | No | No |
| 002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE | No | No |
| 003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No |
| 005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 3MG BASE | No | No |
| 006 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 007 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69452-356 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |
| 69452-357 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |
| 69452-358 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |
| 69452-359 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |
| 69452-360 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |
| 69452-361 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |
| 69452-362 | Ropinirole | Ropinirole | Bionpharma Inc. | ANDA | Current |