NEXIUM - 20MG DIN 02244521
Status: Marketed
Holder: ASTRAZENECA CANADA INC
Available to quote
Health Canada record
| Active ingredient(s) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG |
|---|---|
| Dosage form | Tablet (Delayed-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A02BC05 ESOMEPRAZOLE |
| Original market date | 20-Aug-2001 |
| Current status date | 20-Aug-2001 |
| Source | Health Canada DPD |
Establishment licence of the holder
AstraZeneca Canada Inc. — licence 100421, currently licensed, last inspection rating C (2023-06-12).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02339099 | APO-ESOMEPRAZOLE | APOTEX INC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Marketed |
| 02339102 | APO-ESOMEPRAZOLE | APOTEX INC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 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 |
| 02442493 | ESOMEPRAZOLE | SIVEM PHARMACEUTICALS ULC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Marketed |
| 02394839 | ESOMEPRAZOLE | PRO DOC LIMITEE | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Marketed |
| 02394847 | ESOMEPRAZOLE | PRO DOC LIMITEE | 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 |
| 02520699 | ESOMEPRAZOLE | JAMP PHARMA CORPORATION | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Marketed |
| 02442507 | ESOMEPRAZOLE | SIVEM PHARMACEUTICALS ULC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 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 |
| 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 |
| 02557681 | RIVA-ESOMEPRAZOLE | LABORATOIRE RIVA INC. | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG | Marketed |
| 02557673 | RIVA-ESOMEPRAZOLE | LABORATOIRE RIVA INC. | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 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 |
| 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 |
| 02449587 | ESOMEPRAZOLE | TEVA CANADA LIMITED | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Cancelled Pre Market |
| 02438488 | ESOMEPRAZOLE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG | Cancelled Pre Market |
| 02383047 | MYLAN-ESOMEPRAZOLE | MYLAN PHARMACEUTICALS ULC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40 MG | Cancelled Post Market |
| 02383039 | MYLAN-ESOMEPRAZOLE | MYLAN PHARMACEUTICALS ULC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 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 |
|---|---|---|---|
| 18748 | 2016-11-14 | Supplement to a New Drug Submission (SNDS) | THIS PURPOSE OF THIS SUPPLEMENTAL NEW DRUG SUBMISSION IS TO UPDATE THE LABELLING OF NEXIUM WITH SAFETY INFORMATION WITH RESPECT TO INTERACTION WITH ANTIRETROVIRAL PRODUCTS IN RESPONSE TO HEALTH CANADA'S ADVISEMENT LETTER FOR ALL PROTON-PUMP INHIBITORS |
| 2220 | 2001-08-17 | New Drug Submission (NDS) |