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MINT-ZOPICLONE DIN 02572648

Status: Approved
Holder: MINT PHARMACEUTICALS INC
Molecule: ZOPICLONE

Health Canada record

Active ingredient(s)ZOPICLONE 3.75 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCN05CF01 ZOPICLONE
Original market date
Current status date15-Oct-2026
SourceHealth Canada DPD

Establishment licence of the holder

Mint Pharmaceuticals Inc — licence 101613, currently licensed, last inspection rating C (2023-01-16).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ZOPICLONE

DINProductCompanyFormStrengthStatus
02475847AG-ZOPICLONEANGITA PHARMA INC.TabletZOPICLONE 7.5 MGMarketed
02469154ALTA-ZOPICLONEALTAMED PHARMATabletZOPICLONE 7.5 MGMarketed
02218313APO-ZOPICLONEAPOTEX INCTabletZOPICLONE 7.5 MGMarketed
02245077APO-ZOPICLONEAPOTEX INCTabletZOPICLONE 5 MGMarketed
02481006BIO-ZOPICLONEBIOMED PHARMATabletZOPICLONE 5 MGMarketed
02480999BIO-ZOPICLONEBIOMED PHARMATabletZOPICLONE 3.75 MGApproved
01926799IMOVANESANOFI-AVENTIS CANADA INCTabletZOPICLONE 7.5 MGMarketed
02385600IPG-ZOPICLONEMARCAN PHARMACEUTICALS INCTabletZOPICLONE 7.5 MGApproved
02549271JAMP ZOPICLONEJAMP PHARMA CORPORATIONTabletZOPICLONE 3.75 MGMarketed
02406969JAMP-ZOPICLONE TABLETSJAMP PHARMA CORPORATIONTabletZOPICLONE 5 MGMarketed
02406977JAMP-ZOPICLONE TABLETSJAMP PHARMA CORPORATIONTabletZOPICLONE 7.5 MGMarketed
02468395JAMP-ZOPICLONE TABLETSJAMP PHARMA CORPORATIONTabletZOPICLONE 3.75 MGMarketed
02467941M-ZOPICLONEMANTRA PHARMA INCTabletZOPICLONE 5 MGMarketed
02386771MAR-ZOPICLONEMARCAN PHARMACEUTICALS INCTabletZOPICLONE 5 MGMarketed
02386798MAR-ZOPICLONEMARCAN PHARMACEUTICALS INCTabletZOPICLONE 7.5 MGMarketed
02391716MINT-ZOPICLONEMINT PHARMACEUTICALS INCTabletZOPICLONE 5 MGMarketed
02391724MINT-ZOPICLONEMINT PHARMACEUTICALS INCTabletZOPICLONE 7.5 MGMarketed
02477386NRA-ZOPICLONENORA PHARMA INCTabletZOPICLONE 7.5 MGMarketed
02477378NRA-ZOPICLONENORA PHARMA INCTabletZOPICLONE 5 MGMarketed
02458543PMS-ZOPICLONEPHARMASCIENCE INCTabletZOPICLONE 3.75 MGMarketed
02240606PMS-ZOPICLONEPHARMASCIENCE INCTabletZOPICLONE 7.5 MGMarketed
02243426PMS-ZOPICLONEPHARMASCIENCE INCTabletZOPICLONE 5 MGMarketed
02278030RIVA-ZOPICLONELABORATOIRE RIVA INC.TabletZOPICLONE 5 MGMarketed
02278049RIVA-ZOPICLONELABORATOIRE RIVA INC.TabletZOPICLONE 7.5 MGMarketed
02242481TEVA-ZOPICLONETEVA CANADA LIMITEDTabletZOPICLONE 7.5 MGMarketed
02246534TEVA-ZOPICLONETEVA CANADA LIMITEDTabletZOPICLONE 5 MGMarketed
02282445ZOPICLONESANIS HEALTH INCTabletZOPICLONE 7.5 MGMarketed
02403129ZOPICLONEAPOTEX INCTabletZOPICLONE 7.5 MGApproved
02403110ZOPICLONEAPOTEX INCTabletZOPICLONE 5 MGApproved
02475820AG-ZOPICLONEANGITA PHARMA INC.TabletZOPICLONE 3.75 MGDormant
02363542AVA-ZOPICLONEAVANSTRA INCTabletZOPICLONE 7.5 MGCancelled Post Market
02240823DOM-ZOPICLONEDOMINION PHARMACALTabletZOPICLONE 7.5 MGCancelled Post Market
02246317DOM-ZOPICLONEDOMINION PHARMACALTabletZOPICLONE 5 MGCancelled Post Market
02216167IMOVANESANOFI-AVENTIS CANADA INCTabletZOPICLONE 5.0 MGCancelled Post Market
02356791JAMP-ZOPICLONEJAMP PHARMA CORPORATIONTabletZOPICLONE 5 MGCancelled Pre Market
02238596MYLAN-ZOPICLONEMYLAN PHARMACEUTICALS ULCTabletZOPICLONE 7.5 MGCancelled Post Market
02251469NOVO-ZOPICLONENOVOPHARM LIMITEDTabletZOPICLONE 7.5 MGCancelled Post Market
02251450NOVO-ZOPICLONENOVOPHARM LIMITEDTabletZOPICLONE 5 MGCancelled Post Market
02477351NRA-ZOPICLONENORA PHARMA INCTabletZOPICLONE 3.75 MGDormant
02381826NTP-ZOPICLONETEVA CANADA LIMITEDTabletZOPICLONE 7.5 MGCancelled Pre Market
02228270NU-ZOPICLONE TABLETS - 7.5MGNU-PHARM INCTabletZOPICLONE 7.5 MGCancelled Post Market
02294052PHL-ZOPICLONEPHARMEL INCTabletZOPICLONE 5 MGCancelled Post Market
02338920Q-ZOPICLONEQD PHARMACEUTICALS ULCTabletZOPICLONE 7.5 MGCancelled Post Market
02257572SANDOZ ZOPICLONESANDOZ CANADA INCORPORATEDTabletZOPICLONE 5 MGCancelled Post Market
02470845SANDOZ ZOPICLONE TABLETSANDOZ CANADA INCORPORATEDTabletZOPICLONE 5 MGCancelled Pre Market
02008203SANDOZ ZOPICLONE TABLETSANDOZ CANADA INCORPORATEDTabletZOPICLONE 7.5 MGCancelled Post Market
02386909SEPTA-ZOPICLONESEPTA PHARMACEUTICALS INCTabletZOPICLONE 5 MGDormant
02386917SEPTA-ZOPICLONESEPTA PHARMACEUTICALS INCTabletZOPICLONE 7.5 MGDormant
02419165SI-ZOPICLONESILAS HEALTHCARE INCTabletZOPICLONE 7.5 MGCancelled Pre Market
02419130SI-ZOPICLONESILAS HEALTHCARE INCTabletZOPICLONE 5 MGCancelled Pre Market
02267918TARO-ZOPICLONESUN PHARMA CANADA INCTabletZOPICLONE 5 MGDormant
02242480TEVA-ZOPICLONETEVA CANADA LIMITEDTabletZOPICLONE 3.75 MGCancelled Post Market
02248207ZOCLONEPREMPHARM INCTabletZOPICLONE 7.5 MGCancelled Post Market
02321548ZOPICLONEMELIAPHARM INCTabletZOPICLONE 7.5 MGCancelled Post Market
02405431ZOPICLONEABRI PHARMACEUTICALS INCTabletZOPICLONE 5 MGCancelled Pre Market
02344599ZOPICLONECOBALT PHARMACEUTICALS COMPANYTabletZOPICLONE 7.5 MGCancelled Pre Market
02405458ZOPICLONEABRI PHARMACEUTICALS INCTabletZOPICLONE 7.5 MGCancelled Pre Market
02321521ZOPICLONEMELIAPHARM INCTabletZOPICLONE 5 MGCancelled Post Market
02425882ZOPICLONE TABLETSNORA PHARMA INCTabletZOPICLONE 7.5 MGCancelled Post Market
02223317ZOPICLONE-7.5 - TAB 7.5MGPRO DOC LIMITEETabletZOPICLONE 7.5 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
384832026-10-15Abbreviated New Drug Submission (ANDS)

International API supply for ZOPICLONE

6 valid EDQM Certificates of Suitability from 6 holders. 21 active FDA Drug Master Files.

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