JAMP-ZOPICLONE DIN 02356805
Health Canada record
| Active ingredient(s) | ZOPICLONE 7.5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05CF01 ZOPICLONE |
| Original market date | 02-Nov-2011 |
| Current status date | 07-Sep-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Jamp Pharma Corporation — licence 100590, currently licensed, last inspection rating C (2025-01-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ZOPICLONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02218313 | APO-ZOPICLONE | APOTEX INC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02245077 | APO-ZOPICLONE | APOTEX INC | Tablet | ZOPICLONE 5 MG | Marketed |
| 01926799 | IMOVANE | SANOFI-AVENTIS CANADA INC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02385597 | IPG-ZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ZOPICLONE 5 MG | Approved |
| 02385600 | IPG-ZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ZOPICLONE 7.5 MG | Approved |
| 02386771 | MAR-ZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ZOPICLONE 5 MG | Marketed |
| 02386798 | MAR-ZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02391716 | MINT-ZOPICLONE | MINT PHARMACEUTICALS INC | Tablet | ZOPICLONE 5 MG | Marketed |
| 02391724 | MINT-ZOPICLONE | MINT PHARMACEUTICALS INC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02243426 | PMS-ZOPICLONE | PHARMASCIENCE INC | Tablet | ZOPICLONE 5 MG | Marketed |
| 02240606 | PMS-ZOPICLONE | PHARMASCIENCE INC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02313073 | PRO-ZOPICLONE | PRO DOC LIMITEE | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02313065 | PRO-ZOPICLONE | PRO DOC LIMITEE | Tablet | ZOPICLONE 5 MG | Marketed |
| 02278030 | RIVA-ZOPICLONE | LABORATOIRE RIVA INC. | Tablet | ZOPICLONE 5 MG | Marketed |
| 02278049 | RIVA-ZOPICLONE | LABORATOIRE RIVA INC. | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02246534 | TEVA-ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 5 MG | Marketed |
| 02242481 | TEVA-ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02403129 | ZOPICLONE | APOTEX INC | Tablet | ZOPICLONE 7.5 MG | Approved |
| 02385848 | ZOPICLONE | SIVEM PHARMACEUTICALS ULC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02385821 | ZOPICLONE | SIVEM PHARMACEUTICALS ULC | Tablet | ZOPICLONE 5 MG | Marketed |
| 02403110 | ZOPICLONE | APOTEX INC | Tablet | ZOPICLONE 5 MG | Approved |
| 02344122 | ZOPICLONE | SANIS HEALTH INC | Tablet | ZOPICLONE 5 MG | Marketed |
| 02282445 | ZOPICLONE | SANIS HEALTH INC | Tablet | ZOPICLONE 7.5 MG | Marketed |
| 02271958 | ACT ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02271931 | ACT ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02363542 | AVA-ZOPICLONE | AVANSTRA INC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02363534 | AVA-ZOPICLONE | AVANSTRA INC | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02246317 | DOM-ZOPICLONE | DOMINION PHARMACAL | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02240823 | DOM-ZOPICLONE | DOMINION PHARMACAL | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02216167 | IMOVANE | SANOFI-AVENTIS CANADA INC | Tablet | ZOPICLONE 5.0 MG | Cancelled Post Market |
| 02356791 | JAMP-ZOPICLONE | JAMP PHARMA CORPORATION | Tablet | ZOPICLONE 5 MG | Cancelled Pre Market |
| 02238596 | MYLAN-ZOPICLONE | MYLAN PHARMACEUTICALS ULC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02296616 | MYLAN-ZOPICLONE | MYLAN PHARMACEUTICALS ULC | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02251450 | NOVO-ZOPICLONE | NOVOPHARM LIMITED | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02251469 | NOVO-ZOPICLONE | NOVOPHARM LIMITED | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02381818 | NTP-ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 5 MG | Cancelled Pre Market |
| 02381826 | NTP-ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 7.5 MG | Cancelled Pre Market |
| 02381796 | NTP-ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 3.75 MG | Cancelled Pre Market |
| 02335034 | NU-ZOPICLONE | NU-PHARM INC | Tablet | ZOPICLONE 7.5 MG | Cancelled (Unreturned Annual) |
| 02334933 | NU-ZOPICLONE | NU-PHARM INC | Tablet | ZOPICLONE 5 MG | Cancelled (Unreturned Annual) |
| 02228270 | NU-ZOPICLONE TABLETS - 7.5MG | NU-PHARM INC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02294052 | PHL-ZOPICLONE | PHARMEL INC | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02294060 | PHL-ZOPICLONE | PHARMEL INC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02338912 | Q-ZOPICLONE | QD PHARMACEUTICALS ULC | Tablet | ZOPICLONE 5 MG | Cancelled Pre Market |
| 02338920 | Q-ZOPICLONE | QD PHARMACEUTICALS ULC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02257572 | SANDOZ ZOPICLONE | SANDOZ CANADA INCORPORATED | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02257580 | SANDOZ ZOPICLONE | SANDOZ CANADA INCORPORATED | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02008203 | SANDOZ ZOPICLONE TABLET | SANDOZ CANADA INCORPORATED | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02386909 | SEPTA-ZOPICLONE | SEPTA PHARMACEUTICALS INC | Tablet | ZOPICLONE 5 MG | Dormant |
| 02386917 | SEPTA-ZOPICLONE | SEPTA PHARMACEUTICALS INC | Tablet | ZOPICLONE 7.5 MG | Dormant |
| 02267926 | TARO-ZOPICLONE | SUN PHARMA CANADA INC | Tablet | ZOPICLONE 7.5 MG | Dormant |
| 02267918 | TARO-ZOPICLONE | SUN PHARMA CANADA INC | Tablet | ZOPICLONE 5 MG | Dormant |
| 02242480 | TEVA-ZOPICLONE | TEVA CANADA LIMITED | Tablet | ZOPICLONE 3.75 MG | Cancelled Post Market |
| 02248207 | ZOCLONE | PREMPHARM INC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02344580 | ZOPICLONE | COBALT PHARMACEUTICALS COMPANY | Tablet | ZOPICLONE 5 MG | Cancelled Pre Market |
| 02321548 | ZOPICLONE | MELIAPHARM INC | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
| 02321521 | ZOPICLONE | MELIAPHARM INC | Tablet | ZOPICLONE 5 MG | Cancelled Post Market |
| 02405431 | ZOPICLONE | ABRI PHARMACEUTICALS INC | Tablet | ZOPICLONE 5 MG | Cancelled Pre Market |
| 02344599 | ZOPICLONE | COBALT PHARMACEUTICALS COMPANY | Tablet | ZOPICLONE 7.5 MG | Cancelled Pre Market |
| 02223317 | ZOPICLONE-7.5 - TAB 7.5MG | PRO DOC LIMITEE | Tablet | ZOPICLONE 7.5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 11740 | 2010-09-24 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |
International API supply for ZOPICLONE
6 valid EDQM Certificates of Suitability from 6 holders. 21 active FDA Drug Master Files.
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