DICLOFENAC K DIN 02351684
Health Canada record
| Active ingredient(s) | DICLOFENAC POTASSIUM 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M01AB05 DICLOFENAC |
| Original market date | 15-Jun-2010 |
| Current status date | 18-Jul-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sanis Health Inc. — licence 101796, currently licensed, last inspection rating I (2024-07-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DICLOFENAC POTASSIUM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02567768 | APO-DICLOFENAC POWDER | APOTEX INC | Powder For Solution | DICLOFENAC POTASSIUM 50 MG | Approved |
| 02381680 | CAMBIA | ARALEZ PHARMACEUTICALS CANADA INC | Powder For Solution | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 02563290 | JAMP DICLOFENAC FOR SOLUTION | JAMP PHARMA CORPORATION | Powder For Solution | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 02560631 | RIVA-DICLOFENAC | LABORATOIRE RIVA INC. | Powder For Solution | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 02261774 | SANDOZ DICLOFENAC RAPIDE | SANDOZ CANADA INCORPORATED | Tablet | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 02564475 | TARO-DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION | TARO PHARMACEUTICALS INC | Powder For Solution | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 02239355 | TEVA-DICLOFENAC-K | TEVA CANADA LIMITED | Tablet | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 00881635 | VOLTAREN RAPIDE | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | DICLOFENAC POTASSIUM 50 MG | Marketed |
| 02243433 | APO-DICLO RAPIDE 50 MG TABLETS | APOTEX INC | Tablet | DICLOFENAC POTASSIUM 50 MG | Cancelled Post Market |
| 02346281 | NTP-DICLOFENAC POTASSIUM | TEVA CANADA LIMITED | Tablet | DICLOFENAC POTASSIUM 50 MG | Cancelled Pre Market |
| 02336413 | NU-DICLO RAPIDE | NU-PHARM INC | Tablet | DICLOFENAC POTASSIUM 50 MG | Cancelled (Unreturned Annual) |
| 02239753 | PMS-DICLOFENAC K | PHARMASCIENCE INC | Tablet | DICLOFENAC POTASSIUM 50 MG | Cancelled Post Market |
| 02311461 | PRO-DICLO RAPIDE - 50 | PRO DOC LIMITEE | Tablet | DICLOFENAC POTASSIUM 50 MG | Cancelled Post Market |
| 02240728 | RIVA-DICLOFENAC-K 50MG TABLETS | LABORATOIRE RIVA INC. | Tablet | DICLOFENAC POTASSIUM 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 26587 | 2014-07-11 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Companies |
| 11832 | 2010-11-02 | Supplement to an Abbreviated New Drug Submission (SANDS) | Product name change |
| 11412 | 2010-05-26 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |
International API supply for DICLOFENAC POTASSIUM
4 valid EDQM Certificates of Suitability from 4 holders. 7 active FDA Drug Master Files.
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