Skip to contentApplication 079050
- Type
- ANDA
- Sponsor
- CELLTRION
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55648-154 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-155 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-171 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-172 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-174 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-175 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-177 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 64679-154 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-155 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-171 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-172 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-174 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-175 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-177 | ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | Wockhardt USA LLC. | ANDA | Current |