ESOMEPRAZOLE DIN 02394847

Status: Marketed

Holder: PRO DOC LIMITEE

Molecule: ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Health Canada record

Active ingredient(s)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG
Dosage form	Tablet (Delayed-Release)
Route	Oral
Schedule	PRESCRIPTION
Class	Human
ATC	A02BC05 ESOMEPRAZOLE
Original market date	22-Nov-2012
Current status date	27-Aug-2021
Source	Health Canada DPD

Establishment licence of the holder

Pro Doc Limitée — licence 100182, currently licensed, last inspection rating C (2025-08-11).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

DIN	Product	Company	Form	Strength	Status
02339102	APO-ESOMEPRAZOLE	APOTEX INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02339099	APO-ESOMEPRAZOLE	APOTEX INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02560194	APO-ESOMEPRAZOLE DELAYED-RELEASE	APOTEX INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Approved
02560186	APO-ESOMEPRAZOLE DELAYED-RELEASE	APOTEX INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Approved
02442507	ESOMEPRAZOLE	SIVEM PHARMACEUTICALS ULC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02520702	ESOMEPRAZOLE	JAMP PHARMA CORPORATION	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02394839	ESOMEPRAZOLE	PRO DOC LIMITEE	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02520699	ESOMEPRAZOLE	JAMP PHARMA CORPORATION	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02442493	ESOMEPRAZOLE	SIVEM PHARMACEUTICALS ULC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02520117	M-ESOMEPRAZOLE	MANTRA PHARMA INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02520109	M-ESOMEPRAZOLE	MANTRA PHARMA INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02479427	MYL-ESOMEPRAZOLE	MYLAN PHARMACEUTICALS ULC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02479419	MYL-ESOMEPRAZOLE	MYLAN PHARMACEUTICALS ULC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02300524	NEXIUM	ASTRAZENECA CANADA INC	Granules For Suspension (Delayed-Release	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 10 MG	Marketed
02244521	NEXIUM - 20MG	ASTRAZENECA CANADA INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02244522	NEXIUM - 40MG	ASTRAZENECA CANADA INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02444712	NEXIUM 24HR	HALEON CANADA ULC	Capsule (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02568322	PRO-ESOMEPRAZOLE	PRO DOC LIMITEE	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Approved
02568314	PRO-ESOMEPRAZOLE	PRO DOC LIMITEE	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Approved
02557673	RIVA-ESOMEPRAZOLE	LABORATOIRE RIVA INC.	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02557681	RIVA-ESOMEPRAZOLE	LABORATOIRE RIVA INC.	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02423987	TARO-ESOMEPRAZOLE	SUN PHARMA CANADA INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Marketed
02423979	TARO-ESOMEPRAZOLE	SUN PHARMA CANADA INC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Marketed
02438488	ESOMEPRAZOLE	RANBAXY PHARMACEUTICALS CANADA INC.	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Cancelled Pre Market
02449587	ESOMEPRAZOLE	TEVA CANADA LIMITED	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Cancelled Pre Market
02449595	ESOMEPRAZOLE	TEVA CANADA LIMITED	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Cancelled Pre Market
02438461	ESOMEPRAZOLE	RANBAXY PHARMACEUTICALS CANADA INC.	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Cancelled Pre Market
02383039	MYLAN-ESOMEPRAZOLE	MYLAN PHARMACEUTICALS ULC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Cancelled Post Market
02383047	MYLAN-ESOMEPRAZOLE	MYLAN PHARMACEUTICALS ULC	Tablet (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Cancelled Post Market
02414392	MYLAN-ESOMEPRAZOLE	MYLAN PHARMACEUTICALS ULC	Capsule (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG	Cancelled Pre Market
02414406	MYLAN-ESOMEPRAZOLE	MYLAN PHARMACEUTICALS ULC	Capsule (Delayed-Release)	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG	Cancelled Pre Market

Notices of Compliance

NOC	Date	Submission	Reason
25544	2021-03-26	Abbreviated New Drug Submission (ANDS)	LICENSING AGREEMENT BETWEEN TWO COMPANIES
13769	2012-10-25	Abbreviated New Drug Submission (ANDS)	New macufacturer and product name

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