PMS-DICLOFENAC DIN 02231502
Health Canada record
| Active ingredient(s) | DICLOFENAC SODIUM 25 MG |
|---|---|
| Dosage form | Tablet (Enteric-Coated) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M01AB05 DICLOFENAC |
| Original market date | 28-Nov-1997 |
| Current status date | 18-Oct-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pharmascience Inc. — licence 100241, currently licensed, last inspection rating C (2025-03-20).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DICLOFENAC SODIUM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00839183 | APO-DICLO | APOTEX INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Marketed |
| 00839175 | APO-DICLO | APOTEX INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 25 MG | Marketed |
| 02091194 | APO-DICLO SR | APOTEX INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Marketed |
| 02162814 | APO-DICLO SR | APOTEX INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Marketed |
| 01917056 | ARTHROTEC 50 | PFIZER CANADA ULC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG; MISOPROSTOL 200 MCG | Marketed |
| 02229837 | ARTHROTEC 75 | PFIZER CANADA ULC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 75 MG; MISOPROSTOL 200 MCG | Marketed |
| 02341689 | GD-DICLOFENAC/MISOPROSTOL 50 | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG; MISOPROSTOL 200 MCG | Marketed |
| 02247265 | PENNSAID | KNIGHT THERAPEUTICS INC. | Solution | DICLOFENAC SODIUM 1.5 % | Marketed |
| 02302616 | PMS-DICLOFENAC | PHARMASCIENCE INC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 25 MG | Marketed |
| 02302624 | PMS-DICLOFENAC | PHARMASCIENCE INC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG | Marketed |
| 00870978 | PRO-DICLOFENAC | PRO DOC LIMITEE | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG | Marketed |
| 02261928 | SANDOZ-DICLOFENAC | SANDOZ CANADA INCORPORATED | Suppository | DICLOFENAC SODIUM 50 MG | Marketed |
| 00808547 | TEVA-DICLOFENAC EC | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Marketed |
| 02158582 | TEVA-DICLOFENAC SR | TEVA CANADA LIMITED | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Marketed |
| 00632724 | VOLTAREN | NOVARTIS PHARMACEUTICALS CANADA INC | Suppository | DICLOFENAC SODIUM 50 MG | Marketed |
| 00870951 | DICLOFENAC ECT 25MG | PRO DOC LIMITEE | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 02224119 | DICLOFENAC-SR | PRO DOC LIMITEE | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 02224127 | DICLOFENAC-SR | PRO DOC LIMITEE | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02237787 | DICLOTEC | TECHNILAB PHARMA INC. | Suppository | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02237786 | DICLOTEC | TECHNILAB PHARMA INC. | Suppository | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02231663 | DOM-DICLOFENAC | DOMINION PHARMACAL | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02231662 | DOM-DICLOFENAC | DOMINION PHARMACAL | Tablet (Delayed-Release) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 02231665 | DOM-DICLOFENAC-SR | DOMINION PHARMACAL | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02231664 | DOM-DICLOFENAC-SR | DOMINION PHARMACAL | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 00886017 | NU-DICLO ENTERIC COATED TAB 25MG | NU-PHARM INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 00886025 | NU-DICLO ENTERIC COATED TAB 50MG | NU-PHARM INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02228211 | NU-DICLO SR - SRT 100MG | NU-PHARM INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02228203 | NU-DICLO SR - SRT 75MG | NU-PHARM INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 02229591 | PENTA-DICLOFENAC - 25MG | PENTAPHARM LTD. | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 02229592 | PENTA-DICLOFENAC - 50MG | PENTAPHARM LTD. | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02231506 | PMS-DICLOFENAC | PHARMASCIENCE INC | Suppository | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02231503 | PMS-DICLOFENAC | PHARMASCIENCE INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02231508 | PMS-DICLOFENAC | PHARMASCIENCE INC | Suppository | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02231505 | PMS-DICLOFENAC-SR | PHARMASCIENCE INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02231504 | PMS-DICLOFENAC-SR | PHARMASCIENCE INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 02236724 | RHO-DICLOFENAC | RHOXALPHARMA INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 25 MG | Cancelled Pre Market |
| 02236725 | RHO-DICLOFENAC | RHOXALPHARMA INC | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Cancelled Pre Market |
| 02240735 | RIVA-DICLOFENAC 100MG SR TABLETS | LABORATOIRE RIVA INC. | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02240733 | RIVA-DICLOFENAC 50MG TABLETS | LABORATOIRE RIVA INC. | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02240734 | RIVA-DICLOFENAC 75MG SR TABLETS | LABORATOIRE RIVA INC. | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 02241224 | SANDOZ DICLOFENAC | SANDOZ CANADA INCORPORATED | Suppository | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02241225 | SANDOZ DICLOFENAC | SANDOZ CANADA INCORPORATED | Suppository | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02261936 | SANDOZ-DICLOFENAC | SANDOZ CANADA INCORPORATED | Suppository | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02261952 | SANDOZ-DICLOFENAC | SANDOZ CANADA INCORPORATED | Tablet (Delayed-Release) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 02261960 | SANDOZ-DICLOFENAC | SANDOZ CANADA INCORPORATED | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02261944 | SANDOZ-DICLOFENAC SR | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02261901 | SANDOZ-DICLOFENAC SR | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 02028662 | TARO-DICLOFENAC TAB 25MG | TARO PHARMACEUTICALS INC | Tablet | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 02028670 | TARO-DICLOFENAC TAB 50MG | TARO PHARMACEUTICALS INC | Tablet | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 02174685 | TEVA-DICLOFENAC | TEVA CANADA LIMITED | Suppository | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 02174677 | TEVA-DICLOFENAC | TEVA CANADA LIMITED | Suppository | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 00808539 | TEVA-DICLOFENAC EC | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
| 02048698 | TEVA-DICLOFENAC SR | TEVA CANADA LIMITED | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Dormant |
| 02238145 | VOFENAL 0.1% | ALCON CANADA INC | Liquid | DICLOFENAC SODIUM 0.1 % | Cancelled Post Market |
| 00632732 | VOLTAREN | NOVARTIS PHARMACEUTICALS CANADA INC | Suppository | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 00514012 | VOLTAREN | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 50 MG | Cancelled Post Market |
| 01940414 | VOLTAREN OPHTHA | NOVARTIS PHARMACEUTICALS CANADA INC | Solution | DICLOFENAC SODIUM 0.1 % | Cancelled Post Market |
| 00590827 | VOLTAREN SR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 100 MG | Cancelled Post Market |
| 00782459 | VOLTAREN SR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet (Extended-Release) | DICLOFENAC SODIUM 75 MG | Cancelled Post Market |
| 00514004 | VOLTAREN TAB 25MG | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet (Delayed-Release) | DICLOFENAC SODIUM 25 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 3715 | 1997-06-27 | New Drug Submission (NDS) |
International API supply for DICLOFENAC SODIUM
10 valid EDQM Certificates of Suitability from 10 holders. 12 active FDA Drug Master Files.
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