BAR-BUPRENORPHINE DIN 02493608
Health Canada record
| Active ingredient(s) | BUPRENORPHINE 5 MCG |
|---|---|
| Dosage form | Patch |
| Route | Transdermal |
| Schedule | NARCOTICS (CDSA I) |
| Class | Human |
| ATC | N02AE01 BUPRENORPHINE |
| Original market date | |
| Current status date | 15-Apr-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bard Pharmaceuticals Ltd. — licence , not currently licensed, last inspection rating C (2025-03-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BUPRENORPHINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02341212 | BUTRANS 10 | PURDUE PHARMA | Patch | BUPRENORPHINE 10 MCG | Marketed |
| 02450771 | BUTRANS 15 | PURDUE PHARMA | Patch | BUPRENORPHINE 15 MCG | Marketed |
| 02341220 | BUTRANS 20 | PURDUE PHARMA | Patch | BUPRENORPHINE 20 MCG | Marketed |
| 02341174 | BUTRANS 5 | PURDUE PHARMA | Patch | BUPRENORPHINE 5 MCG | Marketed |
| 02483084 | SUBLOCADE | INDIVIOR UK LIMITED | Solution (Extended-Release) | BUPRENORPHINE 100 MG | Marketed |
| 02483092 | SUBLOCADE | INDIVIOR UK LIMITED | Solution (Extended-Release) | BUPRENORPHINE 300 MG | Marketed |
| 02493616 | BAR-BUPRENORPHINE | BARD PHARMACEUTICALS (1990) INC | Patch | BUPRENORPHINE 10 MCG | Cancelled Pre Market |
| 02493624 | BAR-BUPRENORPHINE | BARD PHARMACEUTICALS (1990) INC | Patch | BUPRENORPHINE 15 MCG | Cancelled Pre Market |
| 02493632 | BAR-BUPRENORPHINE | BARD PHARMACEUTICALS (1990) INC | Patch | BUPRENORPHINE 20 MCG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22849 | 2019-11-01 | New Drug Submission (NDS) | NEW PRODUCT LABELS AND PRODUCT MONOGRAPH. LICENSING AGREEMENT BETWEEN TWO COMPANIES |
International API supply for BUPRENORPHINE
11 valid EDQM Certificates of Suitability from 10 holders. 28 active FDA Drug Master Files.
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