DOM-RISEDRONATE DIN 02309831
Status: Cancelled Post Market
Holder: DOMINION PHARMACAL
Health Canada record
| Active ingredient(s) | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M05BA07 RISEDRONIC ACID |
| Original market date | 19-Apr-2011 |
| Current status date | 09-May-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Dominion Pharmacal — licence 100967, currently licensed, last inspection rating C (2023-03-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02493268 | AA-RISEDRONATE DR | AA PHARMA INC | Tablet (Delayed-Release) | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02316838 | ACTONEL | ABBVIE CORPORATION | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Marketed |
| 02246896 | ACTONEL | ABBVIE CORPORATION | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02370417 | ACTONEL DR | ABBVIE CORPORATION | Tablet (Delayed-Release) | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02353687 | APO-RISEDRONATE | APOTEX INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02377721 | APO-RISEDRONATE | APOTEX INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Marketed |
| 02406306 | AURO-RISEDRONATE | AURO PHARMA INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02406292 | AURO-RISEDRONATE | AURO PHARMA INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 30 MG | Approved |
| 02406284 | AURO-RISEDRONATE | AURO PHARMA INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 5 MG | Approved |
| 02561859 | NB-RISEDRONATE | NB PHARMA INC. | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02427354 | PENDO-RISEDRONATE | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Approved |
| 02302209 | PMS-RISEDRONATE | PHARMASCIENCE INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02424177 | PMS-RISEDRONATE | PHARMASCIENCE INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Marketed |
| 02528460 | RISEDRONATE | SANIS HEALTH INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Marketed |
| 02347474 | RISEDRONATE | PRO DOC LIMITEE | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02370255 | RISEDRONATE | SANIS HEALTH INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02341077 | RIVA-RISEDRONATE | LABORATOIRE RIVA INC. | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02327295 | SANDOZ RISEDRONATE | SANDOZ CANADA INCORPORATED | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Marketed |
| 02561913 | WAY-RISEDRONATE | WAYMADE CANADA INC. | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Approved |
| 02239146 | ACTONEL | ALLERGAN PHARMA CO. | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 30 MG | Cancelled Post Market |
| 02242518 | ACTONEL | ALLERGAN PHARMA CO. | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 5 MG | Cancelled Post Market |
| 02297787 | ACTONEL | WARNER CHILCOTT CANADA CO | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 75 MG | Cancelled Post Market |
| 02442760 | AURO-RISEDRONATE | AURO PHARMA INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Dormant |
| 02368552 | JAMP-RISEDRONATE | JAMP PHARMA CORPORATION | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Cancelled Post Market |
| 02397773 | MYLAN-RISEDRONATE | MYLAN PHARMACEUTICALS ULC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150 MG | Cancelled Post Market |
| 02357984 | MYLAN-RISEDRONATE | MYLAN PHARMACEUTICALS ULC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Cancelled Post Market |
| 02309874 | PHL-RISEDRONATE | PHARMEL INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Cancelled Pre Market |
| 02362414 | PMS-RISEDRONATE PLUS CALCIUM | PHARMASCIENCE INC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG; CALCIUM (CALCIUM CARBONATE) 500 MG | Cancelled Pre Market |
| 02377446 | Q-RISEDRONATE | QD PHARMACEUTICALS ULC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Cancelled Pre Market |
| 02319861 | RATIO-RISEDRONATE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Cancelled Post Market |
| 02352141 | RISEDRONATE | SIVEM PHARMACEUTICALS ULC | Tablet | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19109 | 2017-03-30 | Supplement to an Abbreviated New Drug Submission (SANDS) | UPDATE TO THE PRODUCT MONOGRAPH |
| 19019 | 2017-02-27 | Supplement to an Abbreviated New Drug Submission (SANDS) | UPDATE TO PRODUCT MONOGRAPH TO BE IN LINE WITH CRP |
| 11756 | 2010-09-29 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |