ORAP DIN 00313815
Health Canada record
| Active ingredient(s) | PIMOZIDE 2 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05AG02 PIMOZIDE |
| Original market date | 31-Dec-1975 |
| Current status date | 28-Jul-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
AA Pharma Inc. — licence 101851, currently licensed, last inspection rating C (2023-05-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PIMOZIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02245432 | PIMOZIDE | AA PHARMA INC | Tablet | PIMOZIDE 2 MG | Marketed |
| 02245433 | PIMOZIDE | AA PHARMA INC | Tablet | PIMOZIDE 4 MG | Marketed |
| 00313823 | ORAP | AA PHARMA INC | Tablet | PIMOZIDE 4 MG | Dormant |
| 00573817 | ORAP TAB 10MG | MCNEIL PHARMACEUTICAL, DIVISION OF ORTHO-MCNEIL INC. | Tablet | PIMOZIDE 10 MG | Cancelled Post Market |
| 02239830 | PMS-PIMOZIDE | PHARMASCIENCE INC | Tablet | PIMOZIDE 4 MG | Cancelled Post Market |
| 02239829 | PMS-PIMOZIDE | PHARMASCIENCE INC | Tablet | PIMOZIDE 2 MG | Cancelled Post Market |
| 02239831 | PMS-PIMOZIDE | PHARMASCIENCE INC | Tablet | PIMOZIDE 10 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 16792 | 2015-04-14 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBERS |
| 13349 | 2012-06-05 | New Drug Submission (NDS) | Manufacturer name change |
| 10637 | 2009-10-05 | New Drug Submission (NDS) | Manufacturer name change |
| 751 | 2002-07-16 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
International API supply for PIMOZIDE
2 valid EDQM Certificates of Suitability from 2 holders. 3 active FDA Drug Master Files.
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