Application 204413
- Type
- ANDA
- Sponsor
- PRINSTON INC
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 |
|---|---|---|---|---|---|
| 43547-554 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-554 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-554 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-554 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-555 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-555 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-555 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-555 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-556 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-556 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-556 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-556 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-557 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-557 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-557 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-557 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-558 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-558 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-558 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |
| 43547-558 | ROPINIROLE | ropinirole | Solco Healthcare US, LLC | ANDA | Current |