MINT-EPLERENONE DIN 02471450
Health Canada record
| Active ingredient(s) | EPLERENONE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C03DA04 EPLERENONE |
| Original market date | 09-Apr-2018 |
| Current status date | 09-Apr-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mint Pharmaceuticals Inc — licence 101613, currently licensed, last inspection rating C (2023-01-16).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing EPLERENONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02465027 | APO-EPLERENONE | APOTEX INC | Tablet | EPLERENONE 50 MG | Approved |
| 02465019 | APO-EPLERENONE | APOTEX INC | Tablet | EPLERENONE 25 MG | Approved |
| 02323052 | INSPRA | BGP PHARMA ULC | Tablet | EPLERENONE 25 MG | Marketed |
| 02323060 | INSPRA | BGP PHARMA ULC | Tablet | EPLERENONE 50 MG | Marketed |
| 02543389 | JAMP EPLERENONE | JAMP PHARMA CORPORATION | Tablet | EPLERENONE 25 MG | Marketed |
| 02543397 | JAMP EPLERENONE | JAMP PHARMA CORPORATION | Tablet | EPLERENONE 50 MG | Marketed |
| 02471442 | MINT-EPLERENONE | MINT PHARMACEUTICALS INC | Tablet | EPLERENONE 25 MG | Marketed |
| 02441578 | GD-EPLERENONE | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet | EPLERENONE 50 MG | Cancelled Pre Market |
| 02441543 | GD-EPLERENONE | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet | EPLERENONE 25 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20228 | 2018-01-04 | Abbreviated New Drug Submission (ANDS) |
International API supply for EPLERENONE
7 valid EDQM Certificates of Suitability from 7 holders. 6 active FDA Drug Master Files.
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