AURO-CLOZAPINE DIN 02455188
Health Canada record
| Active ingredient(s) | CLOZAPINE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05AH02 CLOZAPINE |
| Original market date | |
| Current status date | 26-May-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Auro Pharma Inc — licence 101305, currently licensed, last inspection rating C (2023-09-27).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CLOZAPINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02248035 | AA-CLOZAPINE | AA PHARMA INC | Tablet | CLOZAPINE 100 MG | Marketed |
| 02458756 | AA-CLOZAPINE | AA PHARMA INC | Tablet | CLOZAPINE 200 MG | Marketed |
| 02458748 | AA-CLOZAPINE | AA PHARMA INC | Tablet | CLOZAPINE 50 MG | Marketed |
| 02248034 | AA-CLOZAPINE | AA PHARMA INC | Tablet | CLOZAPINE 25 MG | Marketed |
| 02455218 | AURO-CLOZAPINE | AURO PHARMA INC | Tablet | CLOZAPINE 200 MG | Approved |
| 02455196 | AURO-CLOZAPINE | AURO PHARMA INC | Tablet | CLOZAPINE 100 MG | Approved |
| 02455161 | AURO-CLOZAPINE | AURO PHARMA INC | Tablet | CLOZAPINE 25 MG | Approved |
| 02470039 | CLOZAPINE TABLETS | INNOMAR STRATEGIES INC. | Tablet | CLOZAPINE 100 MG | Approved |
| 02470020 | CLOZAPINE TABLETS | INNOMAR STRATEGIES INC. | Tablet | CLOZAPINE 25 MG | Approved |
| 00894737 | CLOZARIL | HLS THERAPEUTICS INC | Tablet | CLOZAPINE 25 MG | Marketed |
| 00894745 | CLOZARIL | HLS THERAPEUTICS INC | Tablet | CLOZAPINE 100 MG | Marketed |
| 02490668 | CLOZARIL | HLS THERAPEUTICS INC | Tablet | CLOZAPINE 50 MG | Marketed |
| 02490676 | CLOZARIL | HLS THERAPEUTICS INC | Tablet | CLOZAPINE 200 MG | Marketed |
| 02305003 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | CLOZAPINE 50 MG | Marketed |
| 02247244 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | CLOZAPINE 100 MG | Marketed |
| 02247243 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | CLOZAPINE 25 MG | Marketed |
| 02554631 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet (Orally-Disintegrating) | CLOZAPINE 12.5 MG | Marketed |
| 02554658 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet (Orally-Disintegrating) | CLOZAPINE 25 MG | Marketed |
| 02554666 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet (Orally-Disintegrating) | CLOZAPINE 50 MG | Marketed |
| 02554674 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet (Orally-Disintegrating) | CLOZAPINE 100 MG | Marketed |
| 02554682 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet (Orally-Disintegrating) | CLOZAPINE 200 MG | Marketed |
| 02305011 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | CLOZAPINE 200 MG | Marketed |
| 02561654 | JAMP CLOZAPINE | JAMP PHARMA CORPORATION | Tablet | CLOZAPINE 200 MG | Approved |
| 02561611 | JAMP CLOZAPINE | JAMP PHARMA CORPORATION | Tablet | CLOZAPINE 25 MG | Approved |
| 02561646 | JAMP CLOZAPINE | JAMP PHARMA CORPORATION | Tablet | CLOZAPINE 100 MG | Approved |
| 02561638 | JAMP CLOZAPINE | JAMP PHARMA CORPORATION | Tablet | CLOZAPINE 50 MG | Approved |
| 02421097 | GEN-CLOZAPINE | MYLAN PHARMACEUTICALS ULC | Suspension | CLOZAPINE 50 MG | Cancelled Pre Market |
| 02240668 | PMS-CLOZAPINE | PHARMASCIENCE INC | Tablet | CLOZAPINE 25 MG | Cancelled Post Market |
| 02240669 | PMS-CLOZAPINE | PHARMASCIENCE INC | Tablet | CLOZAPINE 100 MG | Cancelled Post Market |
| 02247805 | SANDOZ CLOZAPINE | SANDOZ CANADA INCORPORATED | Tablet | CLOZAPINE 100 MG | Cancelled Pre Market |
| 02247798 | SANDOZ CLOZAPINE | SANDOZ CANADA INCORPORATED | Tablet | CLOZAPINE 25 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18130 | 2016-05-26 | Abbreviated New Drug Submission (ANDS) |
International API supply for CLOZAPINE
7 valid EDQM Certificates of Suitability from 7 holders. 12 active FDA Drug Master Files.
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