SOTALOL DIN 02385996
Health Canada record
| Active ingredient(s) | SOTALOL HYDROCHLORIDE 160 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C07AA07 SOTALOL |
| Original market date | 11-Jun-2012 |
| Current status date | 07-Aug-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sivem Pharmaceuticals ULC — licence 101965, currently licensed, last inspection rating C (2025-02-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SOTALOL HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02565412 | AMB-SOTALOL | AMBICARE PHARMACEUTICALS INC. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Marketed |
| 02565404 | AMB-SOTALOL | AMBICARE PHARMACEUTICALS INC. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Marketed |
| 02167794 | APO-SOTALOL | APOTEX INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Marketed |
| 02210428 | APO-SOTALOL | APOTEX INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Marketed |
| 02238326 | PMS-SOTALOL - 80 MG | PHARMASCIENCE INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Marketed |
| 02200996 | SOTALOL | APOTEX INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Approved |
| 02163772 | SOTALOL | APOTEX INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Approved |
| 02363682 | AVA-SOTALOL | AVANSTRA INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02363674 | AVA-SOTALOL | AVANSTRA INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02270633 | CO SOTALOL | COBALT PHARMACEUTICALS COMPANY | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02270625 | CO SOTALOL | COBALT PHARMACEUTICALS COMPANY | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02238634 | DOM-SOTALOL | DOMINION PHARMACAL | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02238635 | DOM-SOTALOL | DOMINION PHARMACAL | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02238614 | FTP-SOTALOL | FTP-PHARMACAL INC. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02238615 | FTP-SOTALOL | FTP-PHARMACAL INC. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02229780 | GEN-SOTALOL 240MG | GENPHARM ULC | Tablet | SOTALOL HYDROCHLORIDE 240 MG | Cancelled Post Market |
| 02368625 | JAMP-SOTALOL | JAMP PHARMA CORPORATION | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Dormant |
| 02368617 | JAMP-SOTALOL | JAMP PHARMA CORPORATION | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Dormant |
| 02170833 | LINSOTALOL - TAB 80MG | LINSON PHARMA CO. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02170841 | LINSOTALOL -TAB 160MG | LINSON PHARMA CO. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02237269 | MED SOTALOL | MEDICAN PHARMA INCORPORATED | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02237270 | MED SOTALOL | MEDICAN PHARMA INCORPORATED | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02229779 | MYLAN-SOTALOL | MYLAN PHARMACEUTICALS ULC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02229778 | MYLAN-SOTALOL | MYLAN PHARMACEUTICALS ULC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02231182 | NOVO-SOTALOL TAB 160MG | NOVOPHARM LIMITED | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02231181 | NOVO-SOTALOL TAB 80MG | NOVOPHARM LIMITED | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02238769 | PHL-SOTALOL | PHARMEL INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02238768 | PHL-SOTALOL | PHARMEL INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02238327 | PMS-SOTALOL - 160 MG | PHARMASCIENCE INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Dormant |
| 02238328 | PMS-SOTALOL - 240 MG | PHARMASCIENCE INC | Tablet | SOTALOL HYDROCHLORIDE 240 MG | Cancelled Pre Market |
| 02316536 | PRO-SOTALOL | PRO DOC LIMITEE | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02316528 | PRO-SOTALOL | PRO DOC LIMITEE | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02084228 | RATIO-SOTALOL | TEVA CANADA LIMITED | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02084236 | RATIO-SOTALOL | TEVA CANADA LIMITED | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02234016 | RHO-SOTALOL | RHOXALPHARMA INC | Tablet | SOTALOL HYDROCHLORIDE 240 MG | Cancelled Pre Market |
| 02234008 | RHOXAL-SOTALOL | RHOXALPHARMA INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02234013 | RHOXAL-SOTALOL | RHOXALPHARMA INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02272172 | RIVA-SOTALOL | LABORATOIRE RIVA INC. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02242156 | RIVA-SOTALOL | LABORATOIRE RIVA INC. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02242157 | RIVA-SOTALOL | LABORATOIRE RIVA INC. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02272164 | RIVA-SOTALOL | LABORATOIRE RIVA INC. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02230649 | RYLOSOL | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02230651 | RYLOSOL | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | SOTALOL HYDROCHLORIDE 240 MG | Cancelled Post Market |
| 02230650 | RYLOSOL | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02257858 | SANDOZ SOTALOL | SANDOZ CANADA INCORPORATED | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02257831 | SANDOZ SOTALOL | SANDOZ CANADA INCORPORATED | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 00483923 | SOTACOR TAB 160MG | BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 00897280 | SOTACOR TAB 240MG | BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | Tablet | SOTALOL HYDROCHLORIDE 240 MG | Cancelled Post Market |
| 00897272 | SOTACOR TAB 80MG | BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02325217 | SOTALOL | SORRES PHARMA INC | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02325209 | SOTALOL | SORRES PHARMA INC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02385988 | SOTALOL | SIVEM PHARMACEUTICALS ULC | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02222027 | SOTALOL-160 - TAB 160MG | PRO DOC LIMITEE | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02222019 | SOTALOL-80 - TAB 80MG | PRO DOC LIMITEE | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
| 02238415 | SOTAMOL | TECHNILAB PHARMA INC. | Tablet | SOTALOL HYDROCHLORIDE 160 MG | Cancelled Post Market |
| 02238417 | SOTAMOL | TECHNILAB PHARMA INC. | Tablet | SOTALOL HYDROCHLORIDE 80 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 13345 | 2012-06-05 | New Drug Submission (NDS) | New manufacturer and product name |
International API supply for SOTALOL HYDROCHLORIDE
3 valid EDQM Certificates of Suitability from 3 holders. 3 active FDA Drug Master Files.
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