ALDACTAZIDE 50 DIN 00594377
Health Canada record
| Active ingredient(s) | SPIRONOLACTONE 50 MG; HYDROCHLOROTHIAZIDE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C03EA01 HYDROCHLOROTHIAZIDE AND POTASSIUM-SPARING AGENTS |
| Original market date | 31-Dec-1983 |
| Current status date | 01-Apr-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SPIRONOLACTONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02518821 | JAMP SPIRONOLACTONE | JAMP PHARMA CORPORATION | Tablet | SPIRONOLACTONE 25 MG | Marketed |
| 02518848 | JAMP SPIRONOLACTONE | JAMP PHARMA CORPORATION | Tablet | SPIRONOLACTONE 100 MG | Marketed |
| 02488159 | MINT-SPIRONOLACTONE | MINT PHARMACEUTICALS INC | Tablet | SPIRONOLACTONE 100 MG | Marketed |
| 02488140 | MINT-SPIRONOLACTONE | MINT PHARMACEUTICALS INC | Tablet | SPIRONOLACTONE 25 MG | Marketed |
| 02567229 | PRZ-SPIRONOLACTONE | PHARMARIS CANADA INC | Tablet | SPIRONOLACTONE 100 MG | Approved |
| 00613215 | TEVA-SPIRONOLACTONE | TEVA CANADA LIMITED | Tablet | SPIRONOLACTONE 25 MG | Marketed |
| 00613223 | TEVA-SPIRONOLACTONE | TEVA CANADA LIMITED | Tablet | SPIRONOLACTONE 100 MG | Marketed |
| 00657182 | TEVA-SPIRONOLACTONE/HCTZ | TEVA CANADA LIMITED | Tablet | SPIRONOLACTONE 50 MG; HYDROCHLOROTHIAZIDE 50 MG | Marketed |
| 00613231 | TEVA-SPIRONOLACTONE/HCTZ | TEVA CANADA LIMITED | Tablet | SPIRONOLACTONE 25 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 00180408 | ALDACTAZIDE 25 | PFIZER CANADA ULC | Tablet | SPIRONOLACTONE 25 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 00285455 | ALDACTONE 100 MG | PFIZER CANADA ULC | Tablet | SPIRONOLACTONE 100 MG | Cancelled Post Market |
| 00028606 | ALDACTONE 25 MG | PFIZER CANADA ULC | Tablet | SPIRONOLACTONE 25 MG | Cancelled Post Market |
| 00520802 | APO-SPIROZIDE TAB | APOTEX INC | Tablet | SPIRONOLACTONE 25 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02347628 | NTP-SPIRONOLACTONE | NT PHARMA CANADA LTD | Tablet | SPIRONOLACTONE 100 MG | Cancelled Pre Market |
| 02347601 | NTP-SPIRONOLACTONE | NT PHARMA CANADA LTD | Tablet | SPIRONOLACTONE 25 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 3567 | 2003-09-15 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 2573 | 2001-08-22 | New Drug Submission (NDS) |
International API supply for SPIRONOLACTONE
2 valid EDQM Certificates of Suitability from 2 holders. 9 active FDA Drug Master Files.
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