REVIA DIN 02213826
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 | 23-Oct-1997 |
| Current status date | 06-May-2015 |
| Source | Health Canada DPD |
Establishment licence of the holder
Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).
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 |
| 02451883 | NALTREXONE HYDROCHLORIDE TABLETS USP | STERINOVA INC. | 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 |
|---|---|---|---|
| 16872 | 2015-05-05 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 3392 | 2003-05-13 | New Drug Submission (NDS) | |
| 2462 | 2001-11-22 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 3080 | 1998-08-21 | New Drug Submission (NDS) | |
| 4565 | 1996-02-28 | Supplement to a New Drug Submission (SNDS) | NEW FORMULATION |
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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