MYLAN-ESOMEPRAZOLE DIN 02383047
Status: Cancelled Post Market
Holder: MYLAN PHARMACEUTICALS ULC
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 | 14-Aug-2012 |
| Current status date | 16-Jun-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
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 |
| 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 |
| 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 |
| 02449595 | ESOMEPRAZOLE | TEVA CANADA LIMITED | 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 |
| 02438461 | ESOMEPRAZOLE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Cancelled Pre 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 |
| 02383039 | MYLAN-ESOMEPRAZOLE | MYLAN PHARMACEUTICALS ULC | Tablet (Delayed-Release) | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18963 | 2017-02-10 | Supplement to a New Drug Submission (SNDS) | PRODUCT MONOGRAPH UPDATE TO MATCH THE INNOVATOR'S. |
| 13561 | 2012-08-14 | New Drug Submission (NDS) | New manufacturer and product name |