ATOPICA DIN 02282054
Health Canada record
| Active ingredient(s) | CYCLOSPORINE 25 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Veterinary |
| ATC | |
| Original market date | 26-Jan-2007 |
| Current status date | 28-Nov-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Elanco Canada Limited — licence 102236, currently licensed, last inspection rating C (2022-08-03).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CYCLOSPORINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02282062 | ATOPICA | ELANCO CANADA LIMITED | Capsule | CYCLOSPORINE 50 MG | Marketed |
| 02282070 | ATOPICA | ELANCO CANADA LIMITED | Capsule | CYCLOSPORINE 100 MG | Marketed |
| 02282046 | ATOPICA | ELANCO CANADA LIMITED | Capsule | CYCLOSPORINE 10 MG | Marketed |
| 02382490 | ATOPICA FOR CATS | ELANCO CANADA LIMITED | Solution | CYCLOSPORINE 100 MG | Marketed |
| 02512629 | CEQUA | SUN PHARMACEUTICAL INDUSTRIES LIMITED | Solution | CYCLOSPORINE 0.09 % | Marketed |
| 02237671 | NEORAL | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | CYCLOSPORINE 10 MG | Marketed |
| 02150662 | NEORAL | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | CYCLOSPORINE 50 MG | Marketed |
| 02150670 | NEORAL | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | CYCLOSPORINE 100 MG | Marketed |
| 02150689 | NEORAL | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | CYCLOSPORINE 25 MG | Marketed |
| 02150697 | NEORAL | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | CYCLOSPORINE 100 MG | Marketed |
| 02142155 | OPTIMMUNE | INTERVET CANADA CORP | Ointment | CYCLOSPORINE 2 MG | Marketed |
| 02355655 | RESTASIS | ABBVIE CORPORATION | Emulsion | CYCLOSPORINE 0.05 % | Marketed |
| 02476835 | RESTASIS MULTIDOSE | ABBVIE CORPORATION | Emulsion | CYCLOSPORINE 0.05 % | Marketed |
| 00593257 | SANDIMMUNE I.V. | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | CYCLOSPORINE 50 MG | Marketed |
| 02247074 | SANDOZ CYCLOSPORINE | SANDOZ CANADA INCORPORATED | Capsule | CYCLOSPORINE 50 MG | Marketed |
| 02242821 | SANDOZ CYCLOSPORINE | SANDOZ CANADA INCORPORATED | Capsule | CYCLOSPORINE 100 MG | Marketed |
| 02247073 | SANDOZ CYCLOSPORINE | SANDOZ CANADA INCORPORATED | Capsule | CYCLOSPORINE 25 MG | Marketed |
| 02462486 | TEVA-CYCLOSPORINE | TEVA CANADA LIMITED | Emulsion | CYCLOSPORINE 0.05 % | Marketed |
| 02484137 | VERKAZIA | APOTEX INC | Emulsion | CYCLOSPORINE 0.1 % | Marketed |
| 02244324 | APO-CYCLOSPORINE ORAL SOLUTION | APOTEX INC | Solution | CYCLOSPORINE 100 MG | Cancelled Post Market |
| 02495813 | CYCLOSPORINE | EDENBRIDGE PHARMACEUTICALS, LLC | Capsule | CYCLOSPORINE 100 MG | Dormant |
| 02334763 | CYCLOSPORINE | SANDOZ CANADA INCORPORATED | Capsule | CYCLOSPORINE 25 MG | Cancelled Pre Market |
| 02495805 | CYCLOSPORINE | EDENBRIDGE PHARMACEUTICALS, LLC | Capsule | CYCLOSPORINE 25 MG | Dormant |
| 02495821 | CYCLOSPORINE | EDENBRIDGE PHARMACEUTICALS, LLC | Capsule | CYCLOSPORINE 50 MG | Dormant |
| 01907182 | SANDIMMUNE CAP 50MG | SANDOZ CANADA INC | Capsule | CYCLOSPORINE 50 MG | Cancelled Post Market |
| 00593249 | SANDIMMUNE ORAL SOL 100MG/ML | SANDOZ CANADA INC | Liquid | CYCLOSPORINE 100 MG | Cancelled Post Market |
| 00755605 | SANDIMMUNE SOFT GELATIN CAP 100MG | SANDOZ CANADA INC | Capsule | CYCLOSPORINE 100 MG | Cancelled Post Market |
| 00755591 | SANDIMMUNE SOFT GELATINE CAP 25MG | SANDOZ CANADA INC | Capsule | CYCLOSPORINE 25 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17751 | 2016-02-05 | New Drug Submission (NDS) | MERGER - BUYOUT |
| 16227 | 2014-10-28 | Supplement to a New Drug Submission (SNDS) | CHANGES TO CAUTIONS AND ADVERSE REACTIONS SECTIONS |
| 8106 | 2006-06-30 | New Drug Submission (NDS) |
International API supply for CYCLOSPORINE
15 active FDA Drug Master Files.
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