APO-NALTREXONE DIN 02444275
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 | 10-Nov-2015 |
| Current status date | 10-Nov-2015 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NALTREXONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02472945 | CONTRAVE | BAUSCH HEALTH, CANADA INC. | Tablet (Extended-Release) | NALTREXONE HYDROCHLORIDE 8 MG; BUPROPION HYDROCHLORIDE 90 MG | Marketed |
| 02451883 | NALTREXONE HYDROCHLORIDE TABLETS USP | STERINOVA INC. | Tablet | NALTREXONE HYDROCHLORIDE 50 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 |
|---|---|---|---|
| 17169 | 2015-08-05 | 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.
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