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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091395-001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | |
| A091395-002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | |
| A091395-003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | |
| A091395-004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | |
| A091395-005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091395-001 | AB |
| A091395-002 | AB |
| A091395-003 | AB |
| A091395-004 | AB |
| A091395-005 | 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 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-001 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-002 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-003 | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-004 | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-005 | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-08-27 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091395-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091395-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091395-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091395-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091395-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091395-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091395-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091395-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091395-005 | AB | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|
| 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 |