LURASIDONE DIN 02548607
Health Canada record
| Active ingredient(s) | LURASIDONE HYDROCHLORIDE 60 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05AE05 LURASIDONE |
| Original market date | 17-Dec-2024 |
| Current status date | 17-Dec-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sanis Health Inc. — licence 101796, currently licensed, last inspection rating I (2024-07-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LURASIDONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02513986 | AURO-LURASIDONE | AURO PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02514036 | AURO-LURASIDONE | AURO PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Marketed |
| 02514028 | AURO-LURASIDONE | AURO PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02514001 | AURO-LURASIDONE | AURO PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Marketed |
| 02513994 | AURO-LURASIDONE | AURO PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02516438 | JAMP LURASIDONE | JAMP PHARMA CORPORATION | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02516470 | JAMP LURASIDONE | JAMP PHARMA CORPORATION | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Marketed |
| 02516462 | JAMP LURASIDONE | JAMP PHARMA CORPORATION | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02516454 | JAMP LURASIDONE | JAMP PHARMA CORPORATION | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Marketed |
| 02516446 | JAMP LURASIDONE | JAMP PHARMA CORPORATION | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02548623 | LURASIDONE | SANIS HEALTH INC | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Approved |
| 02548585 | LURASIDONE | SANIS HEALTH INC | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02548593 | LURASIDONE | SANIS HEALTH INC | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02548615 | LURASIDONE | SANIS HEALTH INC | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02522322 | NRA-LURASIDONE | NORA PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02522314 | NRA-LURASIDONE | NORA PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02522357 | NRA-LURASIDONE | NORA PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Approved |
| 02522349 | NRA-LURASIDONE | NORA PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02522330 | NRA-LURASIDONE | NORA PHARMA INC | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Marketed |
| 02505916 | PMS-LURASIDONE | PHARMASCIENCE INC | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Marketed |
| 02505878 | PMS-LURASIDONE | PHARMASCIENCE INC | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02505886 | PMS-LURASIDONE | PHARMASCIENCE INC | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02505894 | PMS-LURASIDONE | PHARMASCIENCE INC | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Marketed |
| 02505908 | PMS-LURASIDONE | PHARMASCIENCE INC | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02521121 | SANDOZ LURASIDONE | SANDOZ CANADA INCORPORATED | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Marketed |
| 02521075 | SANDOZ LURASIDONE | SANDOZ CANADA INCORPORATED | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02521091 | SANDOZ LURASIDONE | SANDOZ CANADA INCORPORATED | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02521105 | SANDOZ LURASIDONE | SANDOZ CANADA INCORPORATED | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Marketed |
| 02521113 | SANDOZ LURASIDONE | SANDOZ CANADA INCORPORATED | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02504529 | TARO-LURASIDONE | TARO PHARMACEUTICALS INC | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Marketed |
| 02504499 | TARO-LURASIDONE | TARO PHARMACEUTICALS INC | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Marketed |
| 02504502 | TARO-LURASIDONE | TARO PHARMACEUTICALS INC | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Marketed |
| 02504510 | TARO-LURASIDONE | TARO PHARMACEUTICALS INC | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Marketed |
| 02504537 | TARO-LURASIDONE | TARO PHARMACEUTICALS INC | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Marketed |
| 02387786 | LATUDA | SUMITOMO PHARMA CANADA, INC. | Tablet | LURASIDONE HYDROCHLORIDE 120 MG | Cancelled Post Market |
| 02387751 | LATUDA | SUMITOMO PHARMA CANADA, INC. | Tablet | LURASIDONE HYDROCHLORIDE 40 MG | Cancelled Post Market |
| 02422050 | LATUDA | SUMITOMO PHARMA CANADA, INC. | Tablet | LURASIDONE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02413361 | LATUDA | SUMITOMO PHARMA CANADA, INC. | Tablet | LURASIDONE HYDROCHLORIDE 60 MG | Cancelled Post Market |
| 02387778 | LATUDA | SUMITOMO PHARMA CANADA, INC. | Tablet | LURASIDONE HYDROCHLORIDE 80 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 33441 | 2024-06-13 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Manufacturers |
International API supply for LURASIDONE HYDROCHLORIDE
32 active FDA Drug Master Files.
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