Application 091395
- Type
- ANDA
- Sponsor
- CELLTRION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | No | No |
| 002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | No | No |
| 003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 6MG BASE | No | No |
| 004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE | No | No |
| 005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55648-771 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-773 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-774 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-775 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-776 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt Limited | ANDA | Current |
| 64679-771 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-773 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-774 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-775 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-776 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | Wockhardt USA LLC. | ANDA | Current |