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RABEPRAZOLE EC DIN 02356538

Status: Marketed
Holder: SANIS HEALTH INC
Molecule: RABEPRAZOLE SODIUM
Available to quote

Health Canada record

Active ingredient(s)RABEPRAZOLE SODIUM 20 MG
Dosage formTablet (Enteric-Coated)
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCA02BC04 RABEPRAZOLE
Original market date23-Nov-2010
Current status date30-May-2019
SourceHealth Canada DPD

Establishment licence of the holder

Sanis Health Inc. — licence 101796, currently licensed, last inspection rating I (2024-07-23).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing RABEPRAZOLE SODIUM

DINProductCompanyFormStrengthStatus
02484161AG-RABEPRAZOLEANGITA PHARMA INC.Tablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGApproved
02484188AG-RABEPRAZOLEANGITA PHARMA INC.Tablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGApproved
02243796PARIET, ENTERIC-COATED TABLET 10MGJANSSEN INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGMarketed
02243797PARIET, ENTERIC-COATED TABLET 20MGJANSSEN INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGMarketed
02385449RABEPRAZOLESIVEM PHARMACEUTICALS ULCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGMarketed
02385457RABEPRAZOLESIVEM PHARMACEUTICALS ULCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGMarketed
02356511RABEPRAZOLE ECSANIS HEALTH INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGMarketed
02314177SANDOZ RABEPRAZOLESANDOZ CANADA INCORPORATEDTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGMarketed
02314185SANDOZ RABEPRAZOLESANDOZ CANADA INCORPORATEDTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGMarketed
02419793TARO-RABEPRAZOLE ECSUN PHARMA CANADA INCTablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGApproved
02419785TARO-RABEPRAZOLE ECSUN PHARMA CANADA INCTablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGApproved
02422638ABBOTT-RABEPRAZOLEBGP PHARMA ULCTablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02422646ABBOTT-RABEPRAZOLEBGP PHARMA ULCTablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02345579APO-RABEPRAZOLEAPOTEX INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02345587APO-RABEPRAZOLEAPOTEX INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02320460DOM-RABEPRAZOLE ECDOMINION PHARMACALTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02320452DOM-RABEPRAZOLE ECDOMINION PHARMACALTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Pre Market
02415291JAMP RABEPRAZOLEJAMP PHARMA CORPORATIONTablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGDormant
02415283JAMP RABEPRAZOLEJAMP PHARMA CORPORATIONTablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGDormant
02408406MYLAN-RABEPRAZOLEMYLAN PHARMACEUTICALS ULCTablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02408392MYLAN-RABEPRAZOLEMYLAN PHARMACEUTICALS ULCTablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02345994NTP-RABEPRAZOLE ECNT PHARMA CANADA LTDTablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGCancelled Pre Market
02346001NTP-RABEPRAZOLE ECNT PHARMA CANADA LTDTablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGCancelled Pre Market
02381737PAT-RABEPRAZOLEPATRIOT A DIVISION OF JANSSEN INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02381745PAT-RABEPRAZOLEPATRIOT A DIVISION OF JANSSEN INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02310805PMS-RABEPRAZOLE ECPHARMASCIENCE INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGDormant
02310813PMS-RABEPRAZOLE ECPHARMASCIENCE INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGDormant
02315203PRO-RABEPRAZOLEPRO DOC LIMITEETablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02315181PRO-RABEPRAZOLEPRO DOC LIMITEETablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02320614RABEPRAZOLE ECMELIAPHARM INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02320622RABEPRAZOLE ECMELIAPHARM INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02330091RIVA-RABEPRAZOLE ECLABORATOIRE RIVA INC.Tablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02330083RIVA-RABEPRAZOLE ECLABORATOIRE RIVA INC.Tablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02298074TARO-RABEPRAZOLESUN PHARMA CANADA INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 10 MGCancelled Post Market
02298082TARO-RABEPRAZOLESUN PHARMA CANADA INCTablet (Enteric-Coated)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02296640TEVA-RABEPRAZOLE ECTEVA CANADA LIMITEDTablet (Delayed-Release)RABEPRAZOLE SODIUM 20 MGCancelled Post Market
02296632TEVA-RABEPRAZOLE ECTEVA CANADA LIMITEDTablet (Delayed-Release)RABEPRAZOLE SODIUM 10 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
161352014-09-26Abbreviated New Drug Submission (ANDS)LICENSING AGREEMENT BETWEEN TWO COMPANIES
158552014-07-21Abbreviated New Drug Submission (ANDS)LICENSING AGREEMENT BETWEEN TWO COMPANIES
118542010-11-08Abbreviated New Drug Submission (ANDS)New manufacturer and product name

International API supply for RABEPRAZOLE SODIUM

1 valid EDQM Certificates of Suitability from 1 holders. 16 active FDA Drug Master Files.

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