Skip to contentApplication 204022
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|
| 16729-232 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-232 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-232 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-232 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-233 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-233 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-233 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-233 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-234 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-234 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-234 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-234 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-235 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-235 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-235 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-235 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-236 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-236 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-236 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-236 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-237 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-237 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-237 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-237 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-238 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-238 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-238 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 16729-238 | ropinirole | ropinirole | Accord Healthcare Inc. | ANDA | Current |
| 50090-4803 | ropinirole | ropinirole | A-S Medication Solutions | ANDA | Current |
| 50090-4803 | ropinirole | ropinirole | A-S Medication Solutions | ANDA | Current |
| 50090-4803 | ropinirole | ropinirole | A-S Medication Solutions | ANDA | Current |
| 50090-4804 | ropinirole | ropinirole | A-S Medication Solutions | ANDA | Current |
| 50090-5167 | ropinirole | ropinirole | A-S Medication Solutions | ANDA | Current |
| 50090-5167 | ropinirole | ropinirole | A-S Medication Solutions | ANDA | Current |
| 63629-8123 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 63629-8123 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 70518-2439 | ropinirole | ropinirole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2439 | ropinirole | ropinirole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2439 | ropinirole | ropinirole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2750 | ropinirole | ropinirole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2750 | ropinirole | ropinirole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2750 | ropinirole | ropinirole | REMEDYREPACK INC. | ANDA | Current |
| 71335-1167 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1167 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1167 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1188 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1188 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1188 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1188 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1231 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1231 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1231 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1231 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1982 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1982 | ropinirole | ropinirole | Bryant Ranch Prepack | ANDA | Current |
| 72189-222 | ROPINIROLE | ROPINIROLE | DIRECT RX | ANDA | Current |
| 72189-222 | ROPINIROLE | ROPINIROLE | DIRECT RX | ANDA | Current |
| 72189-364 | Ropinirole | Ropinirole | Direct_Rx | ANDA | Current |