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CLONIDINE DIN 02540061

Status: Marketed
Holder: SIVEM PHARMACEUTICALS ULC
Molecule: CLONIDINE HYDROCHLORIDE

Health Canada record

Active ingredient(s)CLONIDINE HYDROCHLORIDE 0.025 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC02AC01 CLONIDINE
Original market date02-Feb-2024
Current status date02-Feb-2024
SourceHealth 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 CLONIDINE HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02569493AURO-CLONIDINEAURO PHARMA INCTabletCLONIDINE HYDROCHLORIDE 0.2 MGApproved
02569485AURO-CLONIDINEAURO PHARMA INCTabletCLONIDINE HYDROCHLORIDE 0.1 MGApproved
02538504CLONIDINESIVEM PHARMACEUTICALS ULCTabletCLONIDINE HYDROCHLORIDE 0.2 MGMarketed
02538490CLONIDINESIVEM PHARMACEUTICALS ULCTabletCLONIDINE HYDROCHLORIDE 0.1 MGMarketed
02528207JAMP CLONIDINEJAMP PHARMA CORPORATIONTabletCLONIDINE HYDROCHLORIDE 0.025 MGMarketed
02564505JAMP CLONIDINE TABLETSJAMP PHARMA CORPORATIONTabletCLONIDINE HYDROCHLORIDE 0.1 MGApproved
02564513JAMP CLONIDINE TABLETSJAMP PHARMA CORPORATIONTabletCLONIDINE HYDROCHLORIDE 0.2 MGApproved
02524198MAR-CLONIDINEMARCAN PHARMACEUTICALS INCTabletCLONIDINE HYDROCHLORIDE 0.025 MGMarketed
02534738MINT-CLONIDINEMINT PHARMACEUTICALS INCTabletCLONIDINE HYDROCHLORIDE 0.025 MGMarketed
02462192MINT-CLONIDINEMINT PHARMACEUTICALS INCTabletCLONIDINE HYDROCHLORIDE 0.1 MGMarketed
02462206MINT-CLONIDINEMINT PHARMACEUTICALS INCTabletCLONIDINE HYDROCHLORIDE 0.2 MGMarketed
02515792SANDOZ CLONIDINESANDOZ CANADA INCORPORATEDTabletCLONIDINE HYDROCHLORIDE 0.2 MGMarketed
02515784SANDOZ CLONIDINESANDOZ CANADA INCORPORATEDTabletCLONIDINE HYDROCHLORIDE 0.1 MGMarketed
02516217SANDOZ CLONIDINESANDOZ CANADA INCORPORATEDTabletCLONIDINE HYDROCHLORIDE 0.025 MGMarketed
02046148TEVA-CLONIDINETEVA CANADA LIMITEDTabletCLONIDINE HYDROCHLORIDE 0.2 MGMarketed
02046121TEVA-CLONIDINETEVA CANADA LIMITEDTabletCLONIDINE HYDROCHLORIDE 0.1 MGMarketed
02304163TEVA-CLONIDINETEVA CANADA LIMITEDTabletCLONIDINE HYDROCHLORIDE 0.025 MGMarketed
02248732APO-CLONIDINEAPOTEX INCTabletCLONIDINE HYDROCHLORIDE 0.025 MGCancelled Post Market
00868949APO-CLONIDINE TAB 0.1MGAPOTEX INCTabletCLONIDINE HYDROCHLORIDE 0.1 MGCancelled Post Market
00868957APO-CLONIDINE TAB 0.2MGAPOTEX INCTabletCLONIDINE HYDROCHLORIDE 0.2 MGCancelled Post Market
00259527CATAPRES TAB 0.1MGBOEHRINGER INGELHEIM (CANADA) LTD LTEETabletCLONIDINE HYDROCHLORIDE 0.1 MGCancelled Post Market
00291889CATAPRES TAB 0.2MGBOEHRINGER INGELHEIM (CANADA) LTD LTEETabletCLONIDINE HYDROCHLORIDE 0.2 MGCancelled Post Market
02361302CLONIDINESANIS HEALTH INCTabletCLONIDINE HYDROCHLORIDE 0.1 MGCancelled Post Market
02361299CLONIDINESANIS HEALTH INCTabletCLONIDINE HYDROCHLORIDE 0.025 MGCancelled Post Market
02361310CLONIDINESANIS HEALTH INCTabletCLONIDINE HYDROCHLORIDE 0.2 MGCancelled Post Market
01910396CLONIDINE 0.1PRO DOC LIMITEETabletCLONIDINE HYDROCHLORIDE 0.1 MGCancelled Post Market
00519251DIXARIT TAB 0.025MGBOEHRINGER INGELHEIM (CANADA) LTD LTEETabletCLONIDINE HYDROCHLORIDE 0.025 MGCancelled Post Market
02358581NTP-CLONIDINETEVA CANADA LIMITEDTabletCLONIDINE HYDROCHLORIDE 0.1 MGCancelled Pre Market
02358565NTP-CLONIDINETEVA CANADA LIMITEDTabletCLONIDINE HYDROCHLORIDE 0.025 MGCancelled Pre Market
02358603NTP-CLONIDINETEVA CANADA LIMITEDTabletCLONIDINE HYDROCHLORIDE 0.2 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
313272023-07-28Abbreviated New Drug Submission (ANDS)Administrative: Licensing Agreement Between Two Manufacturers

International API supply for CLONIDINE HYDROCHLORIDE

6 valid EDQM Certificates of Suitability from 6 holders. 7 active FDA Drug Master Files.

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