ONDANSETRON INJECTION, USP DIN 02298929
Status: Cancelled Post Market
Holder: AGILA SPECIALTIES PRIVATE LIMITED
Health Canada record
| Active ingredient(s) | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2.00 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A04AA01 ONDANSETRON |
| Original market date | 26-Mar-2008 |
| Current status date | 05-Jul-2012 |
| Source | Health Canada DPD |
Establishment licence of the holder
Agila Specialties Polska Sp. z o.o. — licence , not currently licensed, last inspection rating C (2019-04-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02288184 | APO-ONDANSETRON | APOTEX INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02288192 | APO-ONDANSETRON | APOTEX INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02291967 | APO-ONDANSETRON | APOTEX INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02297876 | MYLAN-ONDANSETRON | MYLAN PHARMACEUTICALS ULC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02297868 | MYLAN-ONDANSETRON | MYLAN PHARMACEUTICALS ULC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02417839 | NAT-ONDANSETRON | NATCO PHARMA (CANADA) INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02417847 | NAT-ONDANSETRON | NATCO PHARMA (CANADA) INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02325160 | ONDANSETRON | PRO DOC LIMITEE | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02421402 | ONDANSETRON | SANIS HEALTH INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02421410 | ONDANSETRON | SANIS HEALTH INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02274418 | ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION | SANDOZ CANADA INCORPORATED | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Marketed |
| 02461420 | ONDANSETRON INJECTION BP | AURO PHARMA INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Marketed |
| 02462257 | ONDANSETRON INJECTION USP | STERIMAX INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Marketed |
| 02279428 | ONDANSETRON INJECTION USP -(PRESERVATIVE FREE) | SANDOZ CANADA INCORPORATED | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Marketed |
| 02279436 | ONDANSETRON INJECTION USP -(WITH PRESERVATIVE) | SANDOZ CANADA INCORPORATED | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Marketed |
| 02298252 | ONDANSETRON INJECTION, USP | STRIDES PHARMA CANADA INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Approved |
| 02322625 | ONDANSETRON INJECTION, USP | STRIDES PHARMA CANADA INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Approved |
| 02258196 | PMS-ONDANSETRON | PHARMASCIENCE INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02258188 | PMS-ONDANSETRON | PHARMASCIENCE INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02274329 | SANDOZ ONDANSETRON | SANDOZ CANADA INCORPORATED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02274310 | SANDOZ ONDANSETRON | SANDOZ CANADA INCORPORATED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02296357 | TEVA-ONDANSETRON | TEVA CANADA LIMITED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Marketed |
| 02296349 | TEVA-ONDANSETRON | TEVA CANADA LIMITED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Marketed |
| 02362910 | AVA-ONDANSETRON | AVANSTRA INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02458802 | CCP-ONDANSETRON | CELLCHEM PHARMACEUTICALS INC. | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02458810 | CCP-ONDANSETRON | CELLCHEM PHARMACEUTICALS INC. | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02278413 | DOM-ONDANSETRON | DOMINION PHARMACAL | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02278405 | DOM-ONDANSETRON | DOMINION PHARMACAL | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02420414 | JAMP-ONDANSETRON | JAMP PHARMA CORPORATION | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02420422 | JAMP-ONDANSETRON | JAMP PHARMA CORPORATION | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02336510 | NU-ONDANSETRON | NU-PHARM INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled (Unreturned Annual) |
| 02336383 | NU-ONDANSETRON | NU-PHARM INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled (Unreturned Annual) |
| 02336529 | NU-ONDANSETRON | NU-PHARM INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled (Unreturned Annual) |
| 02346095 | ONDANSETRON | MELIAPHARM INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02346168 | ONDANSETRON | MELIAPHARM INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02265532 | ONDANSETRON INJECTION | TEVA CANADA LIMITED | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02265524 | ONDANSETRON INJECTION | TEVA CANADA LIMITED | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02367297 | ONDANSETRON INJECTION USP | ACCORD HEALTHCARE INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Pre Market |
| 02382121 | ONDANSETRON INJECTION USP | ACCORD HEALTHCARE INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Pre Market |
| 02274426 | ONDANSETRON INJECTION USP -(PRESERVATIVE FREE) | HOSPIRA HEALTHCARE ULC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02274434 | ONDANSETRON INJECTION USP -(WITH PRESERVATIVES) | HOSPIRA HEALTHCARE ULC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02390019 | ONDANSETRON INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02322668 | ONDANSETRON INJECTION, USP | AGILA SPECIALTIES PRIVATE LIMITED | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2.00 MG | Cancelled Post Market |
| 02390051 | ONDANSETRON INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02271761 | ONDANSETRON OMEGA -(PRESERVATIVE FREE - SINGLE DOSE VIALS) | OMEGA LABORATORIES LIMITED | Liquid | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02271788 | ONDANSETRON OMEGA -(WITH PRESERVATIVE - MULTIDOSE VIAL) | OMEGA LABORATORIES LIMITED | Liquid | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02278626 | PHL-ONDANSETRON | PHARMEL INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02278618 | PHL-ONDANSETRON | PHARMEL INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02278537 | RATIO-ONDANSETRON | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02278529 | RATIO-ONDANSETRON | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02264056 | TEVA-ONDANSETRON | TEVA CANADA LIMITED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02264064 | TEVA-ONDANSETRON | TEVA CANADA LIMITED | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02448440 | VAN-ONDANSETRON | VANC PHARMACEUTICALS INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02448467 | VAN-ONDANSETRON | VANC PHARMACEUTICALS INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02213567 | ZOFRAN | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02229639 | ZOFRAN | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
| 02213575 | ZOFRAN | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02213745 | ZOFRAN | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2 MG | Cancelled Post Market |
| 02344459 | ZYM-ONDANSETRON | ZYMCAN PHARMACEUTICALS INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8 MG | Cancelled Post Market |
| 02344440 | ZYM-ONDANSETRON | ZYMCAN PHARMACEUTICALS INC | Tablet | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12107 | 2011-02-25 | Abbreviated New Drug Submission (ANDS) | Manufacturer name change |
| 9377 | 2008-02-14 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER NAME CHANGE |
| 9148 | 2007-11-01 | Abbreviated New Drug Submission (ANDS) | NEW MANUFACTURER AND PRODUCT NAME |