NALTREXONE HYDROCHLORIDE TABLETS USP DIN 02451883
Health Canada record
| Active ingredient(s) | NALTREXONE HYDROCHLORIDE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N07BB04 NALTREXONE |
| Original market date | 30-May-2017 |
| Current status date | 30-May-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sterinova Inc — licence 102212, currently licensed, last inspection rating I (2026-04-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NALTREXONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02444275 | APO-NALTREXONE | APOTEX INC | Tablet | NALTREXONE HYDROCHLORIDE 50 MG | Marketed |
| 02472945 | CONTRAVE | BAUSCH HEALTH, CANADA INC. | Tablet (Extended-Release) | NALTREXONE HYDROCHLORIDE 8 MG; BUPROPION HYDROCHLORIDE 90 MG | Marketed |
| 02213826 | REVIA | TEVA CANADA LIMITED | Tablet | NALTREXONE HYDROCHLORIDE 50 MG | Marketed |
| 02558343 | RPC-NALTREXONE | RUSAN PHARMA CANADA INC. | Tablet | NALTREXONE HYDROCHLORIDE 50 MG | Approved |
| 02158655 | REVIA - TAB 50MG | DUPONT MERCK PHARMA INC. | Tablet | NALTREXONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17771 | 2016-02-11 | Abbreviated New Drug Submission (ANDS) |
International API supply for NALTREXONE HYDROCHLORIDE
7 valid EDQM Certificates of Suitability from 7 holders. 9 active FDA Drug Master Files.
Request a quote for NALTREXONE HYDROCHLORIDE TABLETS USP