PEDIAPHARM NAPROXEN SUSPENSION DIN 02162431
Health Canada record
| Active ingredient(s) | NAPROXEN 25 MG |
|---|---|
| Dosage form | Suspension |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | M01AE02 NAPROXEN |
| Original market date | 31-Dec-1996 |
| Current status date | 20-Dec-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Medexus Pharmaceuticals Inc. — licence 101526, currently licensed, last inspection rating C (2026-02-19).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NAPROXEN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00600806 | APO-NAPROXEN | APOTEX INC | Tablet | NAPROXEN 375 MG | Marketed |
| 00592277 | APO-NAPROXEN | APOTEX INC | Tablet | NAPROXEN 500 MG | Marketed |
| 00522651 | APO-NAPROXEN | APOTEX INC | Tablet | NAPROXEN 250 MG | Marketed |
| 02246700 | APO-NAPROXEN EC | APOTEX INC | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Marketed |
| 02246701 | APO-NAPROXEN EC | APOTEX INC | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Marketed |
| 02246699 | APO-NAPROXEN EC TABLETS | APOTEX INC | Tablet (Enteric-Coated) | NAPROXEN 250 MG | Marketed |
| 02162423 | NAPROSYN | SEARCHLIGHT PHARMA INC | Tablet (Delayed-Release) | NAPROXEN 500 MG | Marketed |
| 02162466 | NAPROSYN | SEARCHLIGHT PHARMA INC | Tablet (Extended-Release) | NAPROXEN 750 MG | Marketed |
| 02310953 | PRO-NAPROXEN EC | PRO DOC LIMITEE | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Marketed |
| 00589861 | TEVA-NAPROXEN | TEVA CANADA LIMITED | Tablet | NAPROXEN 500 MG | Marketed |
| 00565350 | TEVA-NAPROXEN | TEVA CANADA LIMITED | Tablet | NAPROXEN 250 MG | Marketed |
| 00627097 | TEVA-NAPROXEN | TEVA CANADA LIMITED | Tablet | NAPROXEN 375 MG | Marketed |
| 02243313 | TEVA-NAPROXEN EC | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Marketed |
| 02243312 | TEVA-NAPROXEN EC | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | NAPROXEN 250 MG | Marketed |
| 02243314 | TEVA-NAPROXEN EC | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Marketed |
| 00522678 | APO NAPROXEN TAB 125MG | APOTEX INC | Tablet | NAPROXEN 125 MG | Dormant |
| 02177072 | APO-NAPROXEN SR TABLETS 750MG | APOTEX INC | Tablet (Extended-Release) | NAPROXEN 750 MG | Dormant |
| 02243432 | MYLAN-NAPROXEN EC | MYLAN PHARMACEUTICALS ULC | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Cancelled Post Market |
| 02241024 | MYLAN-NAPROXEN EC | MYLAN PHARMACEUTICALS ULC | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Cancelled Post Market |
| 02243431 | MYLAN-NAPROXEN EC | MYLAN PHARMACEUTICALS ULC | Tablet (Enteric-Coated) | NAPROXEN 250 MG | Cancelled Post Market |
| 02162415 | NAPROSYN | SEARCHLIGHT PHARMA INC | Tablet (Delayed-Release) | NAPROXEN 375 MG | Cancelled Post Market |
| 00335193 | NAPROSYN 250MG | SYNTEX INC. | Tablet | NAPROXEN 250 MG | Cancelled Post Market |
| 02162474 | NAPROSYN 250MG TABLETS | HOFFMANN-LA ROCHE LIMITED | Tablet | NAPROXEN 250 MG | Cancelled Post Market |
| 00583367 | NAPROSYN 375MG | SYNTEX INC. | Tablet | NAPROXEN 375 MG | Cancelled Post Market |
| 02162482 | NAPROSYN 375MG TABLETS | HOFFMANN-LA ROCHE LIMITED | Tablet | NAPROXEN 375 MG | Cancelled Post Market |
| 02162458 | NAPROSYN 500 MG SUPPOSITORIES | HOFFMANN-LA ROCHE LIMITED | Suppository | NAPROXEN 500 MG | Cancelled Post Market |
| 02162490 | NAPROSYN 500 MG TABLETS | HOFFMANN-LA ROCHE LIMITED | Tablet | NAPROXEN 500 MG | Cancelled Post Market |
| 02162792 | NAPROSYN E 250MG TABLETS - ECT | HOFFMANN-LA ROCHE LIMITED | Tablet (Enteric-Coated) | NAPROXEN 250 MG | Cancelled Post Market |
| 01937340 | NAPROSYN E TAB 250MG | SYNTEX INC. | Tablet (Enteric-Coated) | NAPROXEN 250 MG | Cancelled Post Market |
| 01937359 | NAPROSYN E TAB 375MG | SYNTEX INC. | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Cancelled Post Market |
| 01937332 | NAPROSYN E TAB 500MG | SYNTEX INC. | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Cancelled Post Market |
| 00531022 | NAPROSYN SUP 500MG | SYNTEX INC. | Suppository | NAPROXEN 500 MG | Cancelled Post Market |
| 00587923 | NAPROSYN SUS 25MG/ML | SYNTEX INC. | Suspension | NAPROXEN 25 MG | Cancelled Post Market |
| 00788767 | NAPROSYN-SR TAB 750MG | SYNTEX INC. | Tablet (Extended-Release) | NAPROXEN 750 MG | Cancelled Post Market |
| 00590762 | NAPROXEN - 250 | PRO DOC LIMITEE | Tablet | NAPROXEN 250 MG | Cancelled Post Market |
| 00618721 | NAPROXEN - 500 | PRO DOC LIMITEE | Tablet | NAPROXEN 500 MG | Cancelled Post Market |
| 00590754 | NAPROXEN 125 TAB 125MG | PRO DOC LIMITEE | Tablet | NAPROXEN 125 MG | Cancelled Post Market |
| 00655686 | NAPROXEN-375 | PRO DOC LIMITEE | Tablet | NAPROXEN 375 MG | Cancelled Post Market |
| 00565369 | NOVO-NAPROX TAB 125MG | NOVOPHARM LIMITED | Tablet | NAPROXEN 125 MG | Cancelled Post Market |
| 00865621 | NU-NAPROX TAB 125MG | NU-PHARM INC | Tablet | NAPROXEN 125 MG | Cancelled Post Market |
| 00865648 | NU-NAPROX TAB 250MG | NU-PHARM INC | Tablet | NAPROXEN 250 MG | Cancelled Post Market |
| 00865656 | NU-NAPROX TAB 375MG | NU-PHARM INC | Tablet | NAPROXEN 375 MG | Cancelled Post Market |
| 00865664 | NU-NAPROX TAB 500MG | NU-PHARM INC | Tablet | NAPROXEN 500 MG | Cancelled Post Market |
| 02017237 | PMS-NAPROXEN | PHARMASCIENCE INC | Suppository | NAPROXEN 500 MG | Cancelled Post Market |
| 02294710 | PMS-NAPROXEN EC | PHARMASCIENCE INC | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Cancelled Post Market |
| 02294702 | PMS-NAPROXEN EC | PHARMASCIENCE INC | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Cancelled Post Market |
| 02310945 | PRO-NAPROXEN EC - 375 | PRO DOC LIMITEE | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Cancelled Post Market |
| 00756814 | RATIO-NAPROXEN | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Suppository | NAPROXEN 500 MG | Cancelled Post Market |
| 00615331 | RATIO-NAPROXEN | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | NAPROXEN 500 MG | Cancelled Post Market |
| 00615323 | RATIO-NAPROXEN | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | NAPROXEN 375 MG | Cancelled Post Market |
| 00615315 | RATIO-NAPROXEN | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | NAPROXEN 250 MG | Cancelled Post Market |
| 02231006 | RATIO-NAPROXEN E | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet (Enteric-Coated) | NAPROXEN 500 MG | Cancelled Pre Market |
| 02231005 | RATIO-NAPROXEN E | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet (Enteric-Coated) | NAPROXEN 375 MG | Cancelled Pre Market |
| 02231004 | RATIO-NAPROXEN E | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet (Enteric-Coated) | NAPROXEN 250 MG | Cancelled Pre Market |
| 02229690 | RHODIAPROX - 500MG/SUP | RHODIAPHARM INC | Suppository | NAPROXEN 500 MG | Cancelled Post Market |
| 02240786 | RIVA-NAPROXEN | LABORATOIRE RIVA INC. | Tablet | NAPROXEN 250 MG | Cancelled Post Market |
| 02240787 | RIVA-NAPROXEN | LABORATOIRE RIVA INC. | Tablet | NAPROXEN 375 MG | Cancelled Post Market |
| 02240788 | RIVA-NAPROXEN | LABORATOIRE RIVA INC. | Tablet | NAPROXEN 500 MG | Cancelled Post Market |
| 02230477 | SAB-NAPROXEN | SABEX INC | Suppository | NAPROXEN 500 MG | Cancelled Post Market |
| 02231327 | TEVA-NAPROXEN SR | TEVA CANADA LIMITED | Tablet (Extended-Release) | NAPROXEN 750 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 29738 | 2022-12-20 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 23904 | 2020-07-14 | New Drug Submission (NDS) | Administrative: Merger/Buy-out |
| 17690 | 2016-01-19 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 15860 | 2014-07-21 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 15721 | 2014-06-13 | Supplement to a New Drug Submission (SNDS) | REMOVAL OF THE 250 MG ENTERIC COATED DOSAGE FORM |
| 5187 | 1995-06-05 | New Drug Submission (NDS) |
International API supply for NAPROXEN
7 valid EDQM Certificates of Suitability from 6 holders. 19 active FDA Drug Master Files.
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