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SANDOZ CLOZAPINE DIN 02247798

Status: Cancelled Pre Market
Holder: SANDOZ CANADA INCORPORATED
Molecule: CLOZAPINE

Health Canada record

Active ingredient(s)CLOZAPINE 25 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCN05AH02 CLOZAPINE
Original market date
Current status date25-Jul-2022
SourceHealth Canada DPD

Establishment licence of the holder

Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing CLOZAPINE

DINProductCompanyFormStrengthStatus
02458756AA-CLOZAPINEAA PHARMA INCTabletCLOZAPINE 200 MGMarketed
02458748AA-CLOZAPINEAA PHARMA INCTabletCLOZAPINE 50 MGMarketed
02248034AA-CLOZAPINEAA PHARMA INCTabletCLOZAPINE 25 MGMarketed
02248035AA-CLOZAPINEAA PHARMA INCTabletCLOZAPINE 100 MGMarketed
02455196AURO-CLOZAPINEAURO PHARMA INCTabletCLOZAPINE 100 MGApproved
02455161AURO-CLOZAPINEAURO PHARMA INCTabletCLOZAPINE 25 MGApproved
02455218AURO-CLOZAPINEAURO PHARMA INCTabletCLOZAPINE 200 MGApproved
02455188AURO-CLOZAPINEAURO PHARMA INCTabletCLOZAPINE 50 MGApproved
02470039CLOZAPINE TABLETSINNOMAR STRATEGIES INC.TabletCLOZAPINE 100 MGApproved
02470020CLOZAPINE TABLETSINNOMAR STRATEGIES INC.TabletCLOZAPINE 25 MGApproved
00894737CLOZARILHLS THERAPEUTICS INCTabletCLOZAPINE 25 MGMarketed
00894745CLOZARILHLS THERAPEUTICS INCTabletCLOZAPINE 100 MGMarketed
02490668CLOZARILHLS THERAPEUTICS INCTabletCLOZAPINE 50 MGMarketed
02490676CLOZARILHLS THERAPEUTICS INCTabletCLOZAPINE 200 MGMarketed
02305011GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTabletCLOZAPINE 200 MGMarketed
02247244GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTabletCLOZAPINE 100 MGMarketed
02247243GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTabletCLOZAPINE 25 MGMarketed
02554631GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTablet (Orally-Disintegrating)CLOZAPINE 12.5 MGMarketed
02554658GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTablet (Orally-Disintegrating)CLOZAPINE 25 MGMarketed
02554666GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTablet (Orally-Disintegrating)CLOZAPINE 50 MGMarketed
02554674GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTablet (Orally-Disintegrating)CLOZAPINE 100 MGMarketed
02554682GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTablet (Orally-Disintegrating)CLOZAPINE 200 MGMarketed
02305003GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCTabletCLOZAPINE 50 MGMarketed
02561646JAMP CLOZAPINEJAMP PHARMA CORPORATIONTabletCLOZAPINE 100 MGApproved
02561654JAMP CLOZAPINEJAMP PHARMA CORPORATIONTabletCLOZAPINE 200 MGApproved
02561611JAMP CLOZAPINEJAMP PHARMA CORPORATIONTabletCLOZAPINE 25 MGApproved
02561638JAMP CLOZAPINEJAMP PHARMA CORPORATIONTabletCLOZAPINE 50 MGApproved
02421097GEN-CLOZAPINEMYLAN PHARMACEUTICALS ULCSuspensionCLOZAPINE 50 MGCancelled Pre Market
02240668PMS-CLOZAPINEPHARMASCIENCE INCTabletCLOZAPINE 25 MGCancelled Post Market
02240669PMS-CLOZAPINEPHARMASCIENCE INCTabletCLOZAPINE 100 MGCancelled Post Market
02247805SANDOZ CLOZAPINESANDOZ CANADA INCORPORATEDTabletCLOZAPINE 100 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
160082014-08-28Abbreviated New Drug Submission (ANDS)MERGER - BUYOUT
3712003-07-11Abbreviated New Drug Submission (ANDS)

International API supply for CLOZAPINE

7 valid EDQM Certificates of Suitability from 7 holders. 12 active FDA Drug Master Files.

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