SANDOZ GLICLAZIDE MR DIN 02461331
Health Canada record
| Active ingredient(s) | GLICLAZIDE 60 MG |
|---|---|
| Dosage form | Tablet (Extended-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A10BB09 GLICLAZIDE |
| Original market date | 02-Jun-2017 |
| Current status date | 31-Jul-2026 |
| Source | Health 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 GLICLAZIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02483300 | AG-GLICLAZIDE MR | ANGITA PHARMA INC. | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02483319 | AG-GLICLAZIDE MR | ANGITA PHARMA INC. | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Marketed |
| 02245247 | APO-GLICLAZIDE | APOTEX INC | Tablet | GLICLAZIDE 80 MG | Marketed |
| 02297795 | APO-GLICLAZIDE MR | APOTEX INC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02407124 | APO-GLICLAZIDE MR | APOTEX INC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Marketed |
| 02242987 | DIAMICRON MR | SERVIER CANADA INC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02356422 | DIAMICRON MR | SERVIER CANADA INC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Marketed |
| 02287072 | GLICLAZIDE | SANIS HEALTH INC | Tablet | GLICLAZIDE 80 MG | Marketed |
| 02568047 | GLICLAZIDE MR TABLETS | SANIS HEALTH INC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Approved |
| 02568039 | GLICLAZIDE MR TABLETS | SANIS HEALTH INC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Approved |
| 02429772 | JAMP GLICLAZIDE-MR | JAMP PHARMA CORPORATION | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Marketed |
| 02429764 | JAMP GLICLAZIDE-MR | JAMP PHARMA CORPORATION | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02423286 | MINT-GLICLAZIDE MR | MINT PHARMACEUTICALS INC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02423294 | MINT-GLICLAZIDE MR | MINT PHARMACEUTICALS INC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Marketed |
| 02449765 | MYLAN-GLICLAZIDE MR | MYLAN PHARMACEUTICALS ULC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Approved |
| 02438658 | MYLAN-GLICLAZIDE MR | MYLAN PHARMACEUTICALS ULC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02463571 | TARO-GLICLAZIDE MR | SUN PHARMA CANADA INC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Marketed |
| 02439328 | TARO-GLICLAZIDE MR | SUN PHARMA CANADA INC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Marketed |
| 02238103 | TEVA-GLICLAZIDE | TEVA CANADA LIMITED | Tablet | GLICLAZIDE 80 MG | Marketed |
| 02363518 | AVA-GLICLAZIDE | AVANSTRA INC | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 00765996 | DIAMICRON | SERVIER CANADA INC | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02248210 | GLIC | PREMPHARM INC | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02155850 | GLICLAZIDE -TAB 80MG | PROVAL PHARMA DIVISION OF SERVIER CANADA INC | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02524856 | GLICLAZIDE MR | SANIS HEALTH INC | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Cancelled Post Market |
| 02524864 | GLICLAZIDE MR | SANIS HEALTH INC | Tablet (Extended-Release) | GLICLAZIDE 60 MG | Cancelled Post Market |
| 02248453 | GLICLAZIDE-80 | PRO DOC LIMITEE | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02229519 | MYLAN-GLICLAZIDE | MYLAN PHARMACEUTICALS ULC | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02336316 | NU-GLICLAZIDE | NU-PHARM INC | Tablet | GLICLAZIDE 80 MG | Cancelled (Unreturned Annual) |
| 02294400 | PMS-GLICLAZIDE | PHARMASCIENCE INC | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02254719 | SANDOZ GLICLAZIDE | SANDOZ CANADA INCORPORATED | Tablet | GLICLAZIDE 80 MG | Cancelled Post Market |
| 02461323 | SANDOZ GLICLAZIDE MR | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | GLICLAZIDE 30 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18948 | 2017-02-07 | New Drug Submission (NDS) | LICENSING AGREEMENT BETWEEN TWO COMPANIES |
International API supply for GLICLAZIDE
11 valid EDQM Certificates of Suitability from 11 holders. 1 active FDA Drug Master Files.
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