LUNESTA DIN 02453215
Health Canada record
| Active ingredient(s) | ESZOPICLONE 2 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05CF04 ESZOPICLONE |
| Original market date | 20-Oct-2020 |
| Current status date | 20-Jan-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Knight Therapeutics Inc. — licence 3-002350, currently licensed, last inspection rating C (2025-11-05).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ESZOPICLONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02453207 | LUNESTA | KNIGHT THERAPEUTICS INC. | Tablet | ESZOPICLONE 1 MG | Marketed |
| 02453223 | LUNESTA | KNIGHT THERAPEUTICS INC. | Tablet | ESZOPICLONE 3 MG | Marketed |
| 02551209 | M-ESZOPICLONE | MANTRA PHARMA INC | Tablet | ESZOPICLONE 3 MG | Marketed |
| 02551187 | M-ESZOPICLONE | MANTRA PHARMA INC | Tablet | ESZOPICLONE 1 MG | Marketed |
| 02551195 | M-ESZOPICLONE | MANTRA PHARMA INC | Tablet | ESZOPICLONE 2 MG | Marketed |
| 02549433 | MAR-ESZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ESZOPICLONE 1 MG | Marketed |
| 02549441 | MAR-ESZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ESZOPICLONE 2 MG | Marketed |
| 02549468 | MAR-ESZOPICLONE | MARCAN PHARMACEUTICALS INC | Tablet | ESZOPICLONE 3 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36754 | 2026-01-20 | New Drug Submission (NDS) | Administrative: Change in product ownership |
| 33079 | 2024-04-18 | New Drug Submission (NDS) | Administrative: Manufacturer Name Change |
| 17891 | 2016-03-17 | New Drug Submission (NDS) |
International API supply for ESZOPICLONE
15 active FDA Drug Master Files.
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