ZOFRAN ODT DIN 02239372
Health Canada record
| Active ingredient(s) | ONDANSETRON 4 MG |
|---|---|
| Dosage form | Tablet (Orally-Disintegrating) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A04AA01 ONDANSETRON |
| Original market date | 31-Mar-1999 |
| Current status date | 31-Jul-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ONDANSETRON
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02535327 | ACCEL-ONDANSETRON ODT | ACCEL PHARMA INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02535319 | ACCEL-ONDANSETRON ODT | ACCEL PHARMA INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02511290 | AURO-ONDANSETRON ODT | AURO PHARMA INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02511282 | AURO-ONDANSETRON ODT | AURO PHARMA INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02541351 | JAMP ONDANSETRON ODF | JAMP PHARMA CORPORATION | Film (Soluble) | ONDANSETRON 4 MG | Marketed |
| 02541378 | JAMP ONDANSETRON ODF | JAMP PHARMA CORPORATION | Film (Soluble) | ONDANSETRON 8 MG | Marketed |
| 02556324 | JAMP ONDANSETRON ODT | JAMP PHARMA CORPORATION | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Approved |
| 02556316 | JAMP ONDANSETRON ODT | JAMP PHARMA CORPORATION | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Approved |
| 02514966 | MAR-ONDANSETRON ODT | MARCAN PHARMACEUTICALS INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02514974 | MAR-ONDANSETRON ODT | MARCAN PHARMACEUTICALS INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02487349 | MINT-ONDANSETRON ODT | MINT PHARMACEUTICALS INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02487330 | MINT-ONDANSETRON ODT | MINT PHARMACEUTICALS INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02565129 | NRA-ONDANSETRON ODT | NORA PHARMA INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Approved |
| 02565137 | NRA-ONDANSETRON ODT | NORA PHARMA INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Approved |
| 02519232 | ONDANSETRON ODT | JAMP PHARMA CORPORATION | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02481723 | ONDANSETRON ODT | SANDOZ CANADA INCORPORATED | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02481731 | ONDANSETRON ODT | SANDOZ CANADA INCORPORATED | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02519240 | ONDANSETRON ODT | JAMP PHARMA CORPORATION | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02524279 | ONDANSETRON ODT | SANIS HEALTH INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02524287 | ONDANSETRON ODT | SANIS HEALTH INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02389991 | ONDISSOLVE ODF | TAKEDA CANADA INC | Film (Soluble) | ONDANSETRON 8 MG | Marketed |
| 02389983 | ONDISSOLVE ODF | TAKEDA CANADA INC | Film (Soluble) | ONDANSETRON 4 MG | Marketed |
| 02519445 | PMS-ONDANSETRON ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Marketed |
| 02519453 | PMS-ONDANSETRON ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Marketed |
| 02444682 | ATHENA-ONDANSETRON ODT | ATHENA PHARMACEUTIQUES SAS | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Dormant |
| 02444674 | ATHENA-ONDANSETRON ODT | ATHENA PHARMACEUTIQUES SAS | Tablet (Orally-Disintegrating) | ONDANSETRON 4 MG | Dormant |
| 02239373 | ZOFRAN ODT | SANDOZ CANADA INCORPORATED | Tablet (Orally-Disintegrating) | ONDANSETRON 8 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 30732 | 2023-05-11 | New Drug Submission (NDS) | Administrative: Change in Product Ownership . Removal of formulations from the Product Monograph |
| 17148 | 2015-07-30 | New Drug Submission (NDS) | Transfer of Drug Identification Numbers |
| 2491 | 2001-08-07 | New Drug Submission (NDS) | CHANGE IN MANUFACTURER NAME |
| 3103 | 1998-12-23 | Supplement to a New Drug Submission (SNDS) | NEW DOSAGE FORM |
International API supply for ONDANSETRON
24 active FDA Drug Master Files.
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