TEVA-ROPINIROLE DIN 02316846
Status: Marketed
Holder: TEVA CANADA LIMITED
Molecule: ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
Available to quote
Health Canada record
| Active ingredient(s) | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N04BC04 ROPINIROLE |
| Original market date | 22-Jul-2009 |
| Current status date | 22-May-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).
Canadian shortage reports
| Status | Reason | Estimated resolution | Tier | Updated |
|---|---|---|---|---|
| active | 1MG | 2026-09-04 |
Other Canadian products containing ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02337746 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Approved |
| 02337800 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5.0 MG | Approved |
| 02337797 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 4.0 MG | Approved |
| 02337789 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 3.0 MG | Approved |
| 02337770 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2.0 MG | Approved |
| 02337762 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1.0 MG | Approved |
| 02337754 | APO-ROPINIROLE | APOTEX INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.5 MG | Approved |
| 02564289 | CLEVOR | ORION CORPORATION | Solution | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 30 MG | Approved |
| 02314088 | SPC-ROPINIROLE | SUN PHARMA CANADA INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5 MG | Marketed |
| 02314061 | SPC-ROPINIROLE | SUN PHARMA CANADA INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2 MG | Marketed |
| 02314037 | SPC-ROPINIROLE | SUN PHARMA CANADA INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Marketed |
| 02314045 | SPC-ROPINIROLE | SUN PHARMA CANADA INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.5 MG | Approved |
| 02314053 | SPC-ROPINIROLE | SUN PHARMA CANADA INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1 MG | Marketed |
| 02316854 | TEVA-ROPINIROLE | TEVA CANADA LIMITED | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1 MG | Marketed |
| 02316862 | TEVA-ROPINIROLE | TEVA CANADA LIMITED | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2 MG | Marketed |
| 02316870 | TEVA-ROPINIROLE | TEVA CANADA LIMITED | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5 MG | Marketed |
| 02331187 | DOM-ROPINIROLE | DOMINION PHARMACAL | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2.0 MG | Cancelled Pre Market |
| 02331152 | DOM-ROPINIROLE | DOMINION PHARMACAL | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Pre Market |
| 02331160 | DOM-ROPINIROLE | DOMINION PHARMACAL | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.5 MG | Cancelled Pre Market |
| 02331179 | DOM-ROPINIROLE | DOMINION PHARMACAL | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1.0 MG | Cancelled Pre Market |
| 02331195 | DOM-ROPINIROLE | DOMINION PHARMACAL | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5.0 MG | Cancelled Pre Market |
| 02352354 | JAMP-ROPINIROLE | JAMP PHARMA CORPORATION | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2.0 MG | Dormant |
| 02352338 | JAMP-ROPINIROLE | JAMP PHARMA CORPORATION | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Dormant |
| 02352346 | JAMP-ROPINIROLE | JAMP PHARMA CORPORATION | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1.0 MG | Dormant |
| 02352362 | JAMP-ROPINIROLE | JAMP PHARMA CORPORATION | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5.0 MG | Dormant |
| 02331233 | PHL-ROPINIROLE | PHARMEL INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2.0 MG | Cancelled Pre Market |
| 02331241 | PHL-ROPINIROLE | PHARMEL INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5.0 MG | Cancelled Pre Market |
| 02331209 | PHL-ROPINIROLE | PHARMEL INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Pre Market |
| 02331217 | PHL-ROPINIROLE | PHARMEL INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.5 MG | Cancelled Pre Market |
| 02331225 | PHL-ROPINIROLE | PHARMEL INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1.0 MG | Cancelled Pre Market |
| 02326604 | PMS-ROPINIROLE | PHARMASCIENCE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.5 MG | Cancelled Pre Market |
| 02326590 | PMS-ROPINIROLE | PHARMASCIENCE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Post Market |
| 02326639 | PMS-ROPINIROLE | PHARMASCIENCE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5.0 MG | Cancelled Post Market |
| 02326620 | PMS-ROPINIROLE | PHARMASCIENCE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2 MG | Cancelled Post Market |
| 02326612 | PMS-ROPINIROLE | PHARMASCIENCE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1 MG | Cancelled Post Market |
| 02232567 | REQUIP | GLAXOSMITHKLINE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1 MG | Cancelled Post Market |
| 02232569 | REQUIP | GLAXOSMITHKLINE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5 MG | Cancelled Post Market |
| 02232568 | REQUIP | GLAXOSMITHKLINE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2 MG | Cancelled Post Market |
| 02232565 | REQUIP | GLAXOSMITHKLINE INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Post Market |
| 02345129 | ROPINIROLE | COBALT PHARMACEUTICALS COMPANY | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Pre Market |
| 02345137 | ROPINIROLE | COBALT PHARMACEUTICALS COMPANY | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1 MG | Cancelled Pre Market |
| 02345145 | ROPINIROLE | COBALT PHARMACEUTICALS COMPANY | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2 MG | Cancelled Pre Market |
| 02345153 | ROPINIROLE | COBALT PHARMACEUTICALS COMPANY | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5 MG | Cancelled Pre Market |
| 02353067 | ROPINIROLE | SANIS HEALTH INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2 MG | Cancelled Post Market |
| 02353059 | ROPINIROLE | SANIS HEALTH INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1 MG | Cancelled Post Market |
| 02353075 | ROPINIROLE | SANIS HEALTH INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5 MG | Cancelled Post Market |
| 02353040 | ROPINIROLE | SANIS HEALTH INC | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Post Market |
| 02332426 | ROPINIROLE TABLETS | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1.0 MG | Cancelled Pre Market |
| 02332442 | ROPINIROLE TABLETS | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5.0 MG | Cancelled Pre Market |
| 02332361 | ROPINIROLE TABLETS | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25 MG | Cancelled Pre Market |
| 02332418 | ROPINIROLE TABLETS | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.5 MG | Cancelled Pre Market |
| 02332434 | ROPINIROLE TABLETS | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2.0 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23664 | 2020-05-22 | Supplement to an Abbreviated New Drug Submission (SANDS) | Product name change,Revisions to the Product Monograph, Revisions to the inner and outer labels |
| 22974 | 2019-12-02 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 15583 | 2014-05-07 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 10420 | 2009-07-22 | Abbreviated New Drug Submission (ANDS) |