NRA-OLANZAPINE ODT DIN 02536196
Health Canada record
| Active ingredient(s) | OLANZAPINE 10 MG |
|---|---|
| Dosage form | Tablet (Orally-Disintegrating) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05AH03 OLANZAPINE |
| Original market date | 08-Apr-2024 |
| Current status date | 08-Apr-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 OLANZAPINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02281791 | APO-OLANZAPINE | APOTEX INC | Tablet | OLANZAPINE 2.5 MG | Marketed |
| 02281848 | APO-OLANZAPINE | APOTEX INC | Tablet | OLANZAPINE 15 MG | Marketed |
| 02281821 | APO-OLANZAPINE | APOTEX INC | Tablet | OLANZAPINE 10 MG | Marketed |
| 02281813 | APO-OLANZAPINE | APOTEX INC | Tablet | OLANZAPINE 7.5 MG | Marketed |
| 02281805 | APO-OLANZAPINE | APOTEX INC | Tablet | OLANZAPINE 5 MG | Marketed |
| 02303167 | PMS-OLANZAPINE | PHARMASCIENCE INC | Tablet | OLANZAPINE 7.5 MG | Marketed |
| 02303116 | PMS-OLANZAPINE | PHARMASCIENCE INC | Tablet | OLANZAPINE 2.5 MG | Marketed |
| 02303183 | PMS-OLANZAPINE | PHARMASCIENCE INC | Tablet | OLANZAPINE 15 MG | Marketed |
| 02303175 | PMS-OLANZAPINE | PHARMASCIENCE INC | Tablet | OLANZAPINE 10 MG | Marketed |
| 02303159 | PMS-OLANZAPINE | PHARMASCIENCE INC | Tablet | OLANZAPINE 5 MG | Marketed |
| 02303213 | PMS-OLANZAPINE ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | OLANZAPINE 15 MG | Marketed |
| 02303191 | PMS-OLANZAPINE ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | OLANZAPINE 5 MG | Marketed |
| 02303205 | PMS-OLANZAPINE ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | OLANZAPINE 10 MG | Marketed |
| 02310341 | SANDOZ OLANZAPINE | SANDOZ CANADA INCORPORATED | Tablet | OLANZAPINE 2.5 MG | Marketed |
| 02310368 | SANDOZ OLANZAPINE | SANDOZ CANADA INCORPORATED | Tablet | OLANZAPINE 5.0 MG | Marketed |
| 02310384 | SANDOZ OLANZAPINE | SANDOZ CANADA INCORPORATED | Tablet | OLANZAPINE 10.0 MG | Marketed |
| 02310376 | SANDOZ OLANZAPINE | SANDOZ CANADA INCORPORATED | Tablet | OLANZAPINE 7.5 MG | Marketed |
| 02310392 | SANDOZ OLANZAPINE | SANDOZ CANADA INCORPORATED | Tablet | OLANZAPINE 15.0 MG | Marketed |
| 02276712 | TEVA-OLANZAPINE | TEVA CANADA LIMITED | Tablet | OLANZAPINE 2.5 MG | Marketed |
| 02276739 | TEVA-OLANZAPINE | TEVA CANADA LIMITED | Tablet | OLANZAPINE 7.5 MG | Marketed |
| 02276747 | TEVA-OLANZAPINE | TEVA CANADA LIMITED | Tablet | OLANZAPINE 10 MG | Marketed |
| 02276755 | TEVA-OLANZAPINE | TEVA CANADA LIMITED | Tablet | OLANZAPINE 15 MG | Marketed |
| 02276720 | TEVA-OLANZAPINE | TEVA CANADA LIMITED | Tablet | OLANZAPINE 5 MG | Marketed |
| 02229269 | ZYPREXA | CHEPLAPHARM REGISTRATION GMBH | Tablet | OLANZAPINE 5 MG | Marketed |
| 02229250 | ZYPREXA | CHEPLAPHARM REGISTRATION GMBH | Tablet | OLANZAPINE 2.5 MG | Marketed |
| 02238851 | ZYPREXA | CHEPLAPHARM REGISTRATION GMBH | Tablet | OLANZAPINE 20 MG | Marketed |
| 02238850 | ZYPREXA | CHEPLAPHARM REGISTRATION GMBH | Tablet | OLANZAPINE 15 MG | Marketed |
| 02229285 | ZYPREXA | CHEPLAPHARM REGISTRATION GMBH | Tablet | OLANZAPINE 10 MG | Marketed |
| 02229277 | ZYPREXA | CHEPLAPHARM REGISTRATION GMBH | Tablet | OLANZAPINE 7.5 MG | Marketed |
| 02243086 | ZYPREXA ZYDIS | CHEPLAPHARM REGISTRATION GMBH | Tablet (Orally-Disintegrating) | OLANZAPINE 5 MG | Marketed |
| 02243088 | ZYPREXA ZYDIS | CHEPLAPHARM REGISTRATION GMBH | Tablet (Orally-Disintegrating) | OLANZAPINE 15 MG | Marketed |
| 02243089 | ZYPREXA ZYDIS | CHEPLAPHARM REGISTRATION GMBH | Tablet (Orally-Disintegrating) | OLANZAPINE 20 MG | Marketed |
| 02243087 | ZYPREXA ZYDIS | CHEPLAPHARM REGISTRATION GMBH | Tablet (Orally-Disintegrating) | OLANZAPINE 10 MG | Marketed |
| 02307367 | DOM-OLANZAPINE | DOMINION PHARMACAL | Tablet | OLANZAPINE 15 MG | Cancelled Pre Market |
| 02307324 | DOM-OLANZAPINE | DOMINION PHARMACAL | Tablet | OLANZAPINE 2.5 MG | Cancelled Pre Market |
| 02307332 | DOM-OLANZAPINE | DOMINION PHARMACAL | Tablet | OLANZAPINE 5 MG | Cancelled Pre Market |
| 02307340 | DOM-OLANZAPINE | DOMINION PHARMACAL | Tablet | OLANZAPINE 7.5 MG | Cancelled Pre Market |
| 02307359 | DOM-OLANZAPINE | DOMINION PHARMACAL | Tablet | OLANZAPINE 10 MG | Cancelled Pre Market |
| 02307375 | DOM-OLANZAPINE ODT | DOMINION PHARMACAL | Tablet (Orally-Disintegrating) | OLANZAPINE 5 MG | Cancelled Pre Market |
| 02307383 | DOM-OLANZAPINE ODT | DOMINION PHARMACAL | Tablet (Orally-Disintegrating) | OLANZAPINE 10 MG | Cancelled Pre Market |
| 02307391 | DOM-OLANZAPINE ODT | DOMINION PHARMACAL | Tablet (Orally-Disintegrating) | OLANZAPINE 15 MG | Cancelled Pre Market |
| 02310015 | NU-OLANZAPINE | NU-PHARM INC | Tablet | OLANZAPINE 2.5 MG | Cancelled (Unreturned Annual) |
| 02310031 | NU-OLANZAPINE | NU-PHARM INC | Tablet | OLANZAPINE 5.0 MG | Cancelled (Unreturned Annual) |
| 02310058 | NU-OLANZAPINE | NU-PHARM INC | Tablet | OLANZAPINE 7.5 MG | Cancelled (Unreturned Annual) |
| 02310082 | NU-OLANZAPINE | NU-PHARM INC | Tablet | OLANZAPINE 10.0 MG | Cancelled (Unreturned Annual) |
| 02310090 | NU-OLANZAPINE | NU-PHARM INC | Tablet | OLANZAPINE 15.0 MG | Cancelled (Unreturned Annual) |
| 02301040 | OLANZAPINE | NOVOPHARM LIMITED | Tablet | OLANZAPINE 10 MG | Cancelled Pre Market |
| 02301032 | OLANZAPINE | NOVOPHARM LIMITED | Tablet | OLANZAPINE 7.5 MG | Cancelled Pre Market |
| 02301024 | OLANZAPINE | NOVOPHARM LIMITED | Tablet | OLANZAPINE 5 MG | Cancelled Pre Market |
| 02301016 | OLANZAPINE | NOVOPHARM LIMITED | Tablet | OLANZAPINE 2.5 MG | Cancelled Pre Market |
| 02301059 | OLANZAPINE | NOVOPHARM LIMITED | Tablet | OLANZAPINE 15 MG | Cancelled Pre Market |
| 02307456 | PHL-OLANZAPINE | PHARMEL INC | Tablet | OLANZAPINE 15 MG | Cancelled Post Market |
| 02307421 | PHL-OLANZAPINE | PHARMEL INC | Tablet | OLANZAPINE 7.5 MG | Cancelled Post Market |
| 02307448 | PHL-OLANZAPINE | PHARMEL INC | Tablet | OLANZAPINE 10 MG | Cancelled Post Market |
| 02307405 | PHL-OLANZAPINE | PHARMEL INC | Tablet | OLANZAPINE 2.5 MG | Cancelled Post Market |
| 02307413 | PHL-OLANZAPINE | PHARMEL INC | Tablet | OLANZAPINE 5 MG | Cancelled Post Market |
| 02307464 | PHL-OLANZAPINE ODT | PHARMEL INC | Tablet (Orally-Disintegrating) | OLANZAPINE 5 MG | Cancelled Post Market |
| 02307472 | PHL-OLANZAPINE ODT | PHARMEL INC | Tablet (Orally-Disintegrating) | OLANZAPINE 10 MG | Cancelled Post Market |
| 02307480 | PHL-OLANZAPINE ODT | PHARMEL INC | Tablet (Orally-Disintegrating) | OLANZAPINE 15 MG | Cancelled Post Market |
| 02310406 | SANDOZ OLANZAPINE | SANDOZ CANADA INCORPORATED | Tablet | OLANZAPINE 20.0 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 30334 | 2023-03-16 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Manufacturers |
International API supply for OLANZAPINE
12 valid EDQM Certificates of Suitability from 12 holders. 28 active FDA Drug Master Files.
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