ZOLEDRONIC ACID - A DIN 02421720
Status: Cancelled Pre Market
Holder: SANDOZ CANADA INCORPORATED
Health Canada record
| Active ingredient(s) | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M05BA08 ZOLEDRONIC ACID |
| Original market date | |
| Current status date | 01-Aug-2019 |
| 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 ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02269198 | ACLASTA | SANDOZ CANADA INCORPORATED | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Marketed |
| 02482525 | JAMP-ZOLEDRONIC ACID | JAMP PHARMA CORPORATION | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02415186 | TARO-ZOLEDRONIC ACID CONCENTRATE | TARO PHARMACEUTICALS INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02401606 | ZOLEDRONIC ACID - Z | SANDOZ CANADA INCORPORATED | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02304007 | ZOLEDRONIC ACID CONCENTRATE | APOTEX INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Approved |
| 02424894 | ZOLEDRONIC ACID CONCENTRATE FOR INJECTION | GENERIC MEDICAL PARTNERS INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Approved |
| 02472805 | ZOLEDRONIC ACID FOR INJECTION | MARCAN PHARMACEUTICALS INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02434458 | ZOLEDRONIC ACID FOR INJECTION | FRESENIUS KABI CANADA LTD | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02422425 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | DR REDDY'S LABORATORIES LTD | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02420961 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | STRIDES PHARMA CANADA INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Approved |
| 02564696 | ZOLEDRONIC ACID INJECTION | JUNO PHARMA CANADA INC. | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Approved |
| 02422433 | ZOLEDRONIC ACID INJECTION | DR REDDY'S LABORATORIES LTD | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Marketed |
| 02479311 | ZOLEDRONIC ACID INJECTION | MARCAN PHARMACEUTICALS INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Approved |
| 02248296 | ZOMETA CONCENTRATE | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Marketed |
| 02408449 | ACT ZOLEDRONIC ACID | ACTAVIS PHARMA COMPANY | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Cancelled Pre Market |
| 02408325 | ACT ZOLEDRONIC ACID CONCENTRATE | ACTAVIS PHARMA COMPANY | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Pre Market |
| 02403056 | PMS-ZOLEDRONIC ACID | PHARMASCIENCE INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Post Market |
| 02415100 | TARO-ZOLEDRONIC ACID | TARO PHARMACEUTICALS INC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Cancelled Post Market |
| 02421550 | ZOLEDRONIC ACID FOR INJECTION | PFIZER CANADA ULC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Post Market |
| 02407639 | ZOLEDRONIC ACID FOR INJECTION | TEVA CANADA LIMITED | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Post Market |
| 02444739 | ZOLEDRONIC ACID FOR INJECTION | JUNO PHARMACEUTICALS CORP. | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Post Market |
| 02413701 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | OMEGA LABORATORIES LIMITED | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Post Market |
| 02408082 | ZOLEDRONIC ACID INJECTION | TEVA CANADA LIMITED | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Cancelled Post Market |
| 02420449 | ZOLEDRONIC ACID INJECTION A | PFIZER CANADA ULC | Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG | Cancelled Pre Market |
| 02242725 | ZOMETA LYOPHILIZED POWDER | NOVARTIS PHARMACEUTICALS CANADA INC | Powder For Solution | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 15474 | 2014-03-28 | New Drug Submission (NDS) | LICENSING AGREEMENT BETWEEN TWO COMPANIES |