NRA-URSODIOL DIN 02544024
Health Canada record
| Active ingredient(s) | URSODIOL 500 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A05AA02 URSODEOXYCHOLIC ACID |
| Original market date | 17-Jul-2024 |
| Current status date | 17-Jul-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Nora Pharma Inc — licence 3-002506, currently licensed, last inspection rating C (2022-11-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing URSODIOL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02426900 | GLN-URSODIOL | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | URSODIOL 250 MG | Marketed |
| 02426919 | GLN-URSODIOL | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | URSODIOL 500 MG | Marketed |
| 02472406 | JAMP-URSODIOL | JAMP PHARMA CORPORATION | Tablet | URSODIOL 500 MG | Marketed |
| 02472392 | JAMP-URSODIOL | JAMP PHARMA CORPORATION | Tablet | URSODIOL 250 MG | Marketed |
| 02544032 | NRA-URSODIOL | NORA PHARMA INC | Tablet | URSODIOL 250 MG | Marketed |
| 02427362 | PENDO-URSODIOL C | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | URSODIOL 250 MG | Approved |
| 02427370 | PENDO-URSODIOL C | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | URSODIOL 500 MG | Approved |
| 02273500 | PMS-URSODIOL C | PHARMASCIENCE INC | Tablet | URSODIOL 500 MG | Marketed |
| 02273497 | PMS-URSODIOL C | PHARMASCIENCE INC | Tablet | URSODIOL 250 MG | Marketed |
| 02505363 | AG-URSODIOL | ANGITA PHARMA INC. | Tablet | URSODIOL 250 MG | Dormant |
| 02505371 | AG-URSODIOL | ANGITA PHARMA INC. | Tablet | URSODIOL 500 MG | Dormant |
| 02281295 | DOM-URSODIOL C | DOMINION PHARMACAL | Tablet | URSODIOL 250 MG | Cancelled Post Market |
| 02281309 | DOM-URSODIOL C | DOMINION PHARMACAL | Tablet | URSODIOL 500 MG | Cancelled Post Market |
| 02449129 | MINT-URSODIOL | MINT PHARMACEUTICALS INC | Tablet | URSODIOL 250 MG | Cancelled Pre Market |
| 02449137 | MINT-URSODIOL | MINT PHARMACEUTICALS INC | Tablet | URSODIOL 500 MG | Cancelled Pre Market |
| 02318091 | NOVO-URSODIOL | NOVOPHARM LIMITED | Tablet | URSODIOL 250 MG | Cancelled Pre Market |
| 02318105 | NOVO-URSODIOL | NOVOPHARM LIMITED | Tablet | URSODIOL 500 MG | Cancelled Pre Market |
| 02281317 | PHL-URSODIOL C | PHARMEL INC | Tablet | URSODIOL 250 MG | Cancelled Post Market |
| 02281325 | PHL-URSODIOL C | PHARMEL INC | Tablet | URSODIOL 500 MG | Cancelled Post Market |
| 02262576 | PMS-URSODIOL | PHARMASCIENCE INC | Tablet | URSODIOL 250 MG | Cancelled Pre Market |
| 02238984 | URSO | APTALIS PHARMA CANADA ULC | Tablet | URSODIOL 250 MG | Cancelled Post Market |
| 02245894 | URSO DS | APTALIS PHARMA CANADA ULC | Tablet | URSODIOL 500 MG | Cancelled Post Market |
| 02515520 | URSODIOL C | SANIS HEALTH INC | Tablet | URSODIOL 250 MG | Dormant |
| 02515539 | URSODIOL C | SANIS HEALTH INC | Tablet | URSODIOL 500 MG | Dormant |
| 01945254 | URSOFALK | AXCAN PHARMA INC | Capsule | URSODIOL 250 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32388 | 2023-12-20 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Manufacturers |
International API supply for URSODIOL
14 active FDA Drug Master Files.
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