Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2007-05-18
- Manufacturer :
- SCHERING-PLOUGH CANADA INC.
- Product type:
- Prescription Pharmaceutical
- NOC with conditions:
- No
- Submission type:
- New Drug Submission (NDS)
- Submission class:
- Other
- Therapeutic class:
- PARTIAL OPIATE AGONIST & OPIATE ANTAGONIST
Brand 1 of 1 :
SUBOXONE
Product 1 of 2 :
Drug identification number:
02295695
Dosage form(s):
Tablet
Route(s) of administration:
Sublingual
| Ingredient | Strength |
|---|---|
| NALOXONE HYDROCHLORIDE DIHYDRATE | 0.5 MG/TAB (calculated as base) |
| BUPRENORPHINE HYDROCHLORIDE | 2 MG/TAB (calculated as base) |
Product 2 of 2 :
Drug identification number:
02295709
Dosage form(s):
Tablet
Route(s) of administration:
Sublingual
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 MG/TAB (calculated as base) |
| NALOXONE HYDROCHLORIDE DIHYDRATE | 2 MG/TAB (calculated as base) |