Application 078881
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A078881-001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | ||
| A078881-002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | ||
| A078881-003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | ||
| A078881-004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | ||
| A078881-005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | ||
| A078881-006 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2008-05-05 | ||
| A078881-007 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2008-05-19 |
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 | A078881-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078881-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078881-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078881-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078881-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078881-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2008-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078881-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2008-05-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2008-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078881-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2008-05-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2008-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078881-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2008-05-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2008-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078881-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2008-05-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | 2008-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078881-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 2008-05-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078881-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | 2008-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078881-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | 2008-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078881-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 2008-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078881-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 2008-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078881-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | 2008-05-05 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078881-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078881-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078881-007 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078881-007 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078881-007 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078881-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078881-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078881-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078881-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078881-005 | AB | 1 | 782e0a99824c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5501 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5501 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5501 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5501 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5501 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5501 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5501 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5502 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5503 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5504 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5505 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5525 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5550 | Ropinirole Hydrochloride | ropinirole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-7536 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7537 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7538 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7539 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7567 | Ropinirole Hydrochloride | Ropinirole Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 43353-258 | Ropinirole Hydrochloride | ropinirole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-265 | Ropinirole Hydrochloride | ropinirole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-266 | Ropinirole Hydrochloride | ropinirole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-267 | Ropinirole Hydrochloride | ropinirole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 60429-817 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-817 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply | ANDA | Current |
| 60429-817 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-817 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-818 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-818 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply | ANDA | Current |
| 60429-818 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-818 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-819 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-819 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply | ANDA | Current |
| 60429-819 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-819 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-820 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-820 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply | ANDA | Current |
| 60429-820 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-820 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-821 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-821 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply | ANDA | Current |
| 60429-821 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-821 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-822 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-822 | Ropinirole Hydrochloride | ropinirole | Golden State Medical Supply | ANDA | Current |