Application 204022
- Type
- ANDA
- Sponsor
- ACCORD 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204022-001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | |
| A204022-002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | |
| A204022-003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | |
| A204022-004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | |
| A204022-005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | |
| A204022-006 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-28 | |
| A204022-007 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2017-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204022-001 | AB |
| A204022-002 | AB |
| A204022-003 | AB |
| A204022-004 | AB |
| A204022-005 | AB |
| A204022-006 | AB |
| A204022-007 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204022-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2017-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2017-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2017-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2017-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2017-02-28 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204022-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204022-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204022-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204022-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204022-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204022-007 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204022-005 | AB | 1 | 03ed91905a0d… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ropinirole | ROPINIROLE | Direct_Rx | e1fb0b51-4f8a-965d-e053-2a95a90ad936 | 2025-01-22 | Warnings, Adverse reactions | 204022 ANDA204022 72189-364 |
| ROPINIROLE | ROPINIROLE | DIRECT RX | c2c38b4c-b139-45f2-e053-2995a90a262c | 2025-01-20 | Warnings, Adverse reactions | 204022 ANDA204022 72189-222 |
| ropinirole | ROPINIROLE | Bryant Ranch Prepack | 8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f2 | 2024-10-31 | Warnings, Adverse reactions | 204022 ANDA204022 71335-1231 |
| ropinirole | ROPINIROLE | Bryant Ranch Prepack | ceb3a0cb-8677-4acd-8313-5498201e81d9 | 2024-10-31 | Warnings, Adverse reactions | 204022 ANDA204022 71335-1167 |
| ropinirole | ROPINIROLE | Bryant Ranch Prepack | cb378fb5-6dca-43e9-83bc-3c54eb9c1af7 | 2024-10-31 | Warnings, Adverse reactions | 204022 ANDA204022 71335-1188 |
| ropinirole | ROPINIROLE | Bryant Ranch Prepack | 55bb5cf4-0e12-41b0-bc52-50b26fe408de | 2024-10-31 | Warnings, Adverse reactions | 204022 ANDA204022 71335-1982 |
| ropinirole | ROPINIROLE | Accord Healthcare Inc. | 4a2a5b63-5b14-6975-e054-00144ff8d46c | 2024-10-03 | Warnings, Adverse reactions | 204022 ANDA204022 16729-237 16729-234 16729-233 16729-232 16729-238 16729-236 16729-235 |
| ropinirole | ROPINIROLE | A-S Medication Solutions | 4f4729f8-c910-4a09-a4b4-b4243e7f0105 | 2024-01-08 | Warnings, Adverse reactions | 204022 ANDA204022 50090-4803 |
NDC Listings For This Application#
| 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 |