SUBLINOX DIN 02391678
Health Canada record
| Active ingredient(s) | ZOLPIDEM TARTRATE 5 MG |
|---|---|
| Dosage form | Tablet (Orally-Disintegrating) |
| Route | Sublingual |
| Schedule | TARGETED SUBSTANCES (CDSA IV) |
| Class | Human |
| ATC | N05CF02 ZOLPIDEM |
| Original market date | 28-Jan-2013 |
| Current status date | 05-Jul-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bausch Health Companies Inc. — licence 101880, currently licensed, last inspection rating C (2026-06-01).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ZOLPIDEM TARTRATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02542382 | AG-ZOLPIDEM ODT | ANGITA PHARMA INC. | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Approved |
| 02542390 | AG-ZOLPIDEM ODT | ANGITA PHARMA INC. | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Approved |
| 02434946 | APO-ZOLPIDEM ODT | APOTEX INC | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Marketed |
| 02436159 | APO-ZOLPIDEM ODT | APOTEX INC | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Marketed |
| 02540606 | JAMP ZOLPIDEM ODT | JAMP PHARMA CORPORATION | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Marketed |
| 02540592 | JAMP ZOLPIDEM ODT | JAMP PHARMA CORPORATION | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Marketed |
| 02472848 | MINT-ZOLPIDEM ODT | MINT PHARMACEUTICALS INC | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Marketed |
| 02472821 | MINT-ZOLPIDEM ODT | MINT PHARMACEUTICALS INC | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Marketed |
| 02436183 | PMS-ZOLPIDEM ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Marketed |
| 02436175 | PMS-ZOLPIDEM ODT | PHARMASCIENCE INC | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Marketed |
| 02537346 | PRO-ZOLPIDEM ODT | PRO DOC LIMITEE | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Marketed |
| 02537354 | PRO-ZOLPIDEM ODT | PRO DOC LIMITEE | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Marketed |
| 02370433 | SUBLINOX | BAUSCH HEALTH, CANADA INC. | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Marketed |
| 02439646 | ZOLPIDEM TARTRATE ODT | BAUSCH HEALTH, CANADA INC. | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 5 MG | Approved |
| 02439638 | ZOLPIDEM TARTRATE ODT | BAUSCH HEALTH, CANADA INC. | Tablet (Orally-Disintegrating) | ZOLPIDEM TARTRATE 10 MG | Approved |
| 02205971 | IVADAL | SANOFI-AVENTIS CANADA INC | Tablet | ZOLPIDEM TARTRATE 5 MG | Cancelled Pre Market |
| 02205998 | IVADAL | SANOFI-AVENTIS CANADA INC | Tablet | ZOLPIDEM TARTRATE 10 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22369 | 2019-07-05 | New Drug Submission (NDS) | CHANGE IN PRODUCT OWNERSHIP |
| 16505 | 2015-01-08 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 13588 | 2012-08-27 | Supplement to a New Drug Submission (SNDS) | New strength and patient population: 5 mg tablet )orally disinegrating) for use in the elderly and in patients with hepatic impairment. |
International API supply for ZOLPIDEM TARTRATE
14 valid EDQM Certificates of Suitability from 14 holders. 20 active FDA Drug Master Files.
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