ALEVE NIGHTTIME DIN 02444593
Health Canada record
| Active ingredient(s) | NAPROXEN SODIUM 220 MG; DIPHENHYDRAMINE HYDROCHLORIDE 25 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | NON-PRESCRIPTION DRUGS |
| Class | Human |
| ATC | M01AE02 NAPROXEN |
| Original market date | 24-Feb-2016 |
| Current status date | 24-Feb-2016 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bayer Inc — licence 101029, currently licensed, last inspection rating C (2023-02-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NAPROXEN SODIUM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02436337 | ALEVE BACK AND BODY PAIN | BAYER INC | Capsule | NAPROXEN SODIUM 220 MG | Marketed |
| 02301733 | ALEVE CAPLETS | BAYER INC | Tablet | NAPROXEN SODIUM 220 MG | Marketed |
| 02361795 | ALEVE LIQUID GELS | BAYER INC | Capsule | NAPROXEN SODIUM 220 MG | Marketed |
| 02162725 | ANAPROX | SEARCHLIGHT PHARMA INC | Tablet | NAPROXEN SODIUM 275 MG | Marketed |
| 02162717 | ANAPROX DS | SEARCHLIGHT PHARMA INC | Tablet | NAPROXEN SODIUM 550 MG | Marketed |
| 00784354 | APO-NAPRO-NA | APOTEX INC | Tablet | NAPROXEN SODIUM 275 MG | Marketed |
| 01940309 | APO-NAPRO-NA DS | APOTEX INC | Tablet | NAPROXEN SODIUM 550 MG | Marketed |
| 02372991 | MAXIDOL LIQUID GELS | BAYER INC | Capsule | NAPROXEN SODIUM 220 MG | Marketed |
| 02362430 | NAPROXEN | PHARMASCIENCE INC | Tablet | NAPROXEN SODIUM 220 MG | Marketed |
| 02442922 | NAPROXEN LIQUID GELS | PHARMASCIENCE INC | Capsule | NAPROXEN SODIUM 220 MG | Approved |
| 02396009 | NAPROXEN MENSTRUAL PAIN RELIEF | PHARMASCIENCE INC | Tablet | NAPROXEN SODIUM 220 MG | Marketed |
| 02379309 | NAPROXEN SODIUM CAPLETS | VITA HEALTH PRODUCTS INC | Tablet | NAPROXEN SODIUM 220 MG | Approved |
| 02475227 | NAPROXEN SODIUM CAPSULES | APOTEX INC | Capsule | NAPROXEN SODIUM 220 MG | Approved |
| 02378876 | NAPROXEN SODIUM TABLETS | VITA HEALTH PRODUCTS INC | Tablet | NAPROXEN SODIUM 220 MG | Approved |
| 02561581 | NAPROXEN SODIUM TABLETS USP 220 MG | RPG LIFE SCIENCES LIMITED | Tablet | NAPROXEN SODIUM 220 MG | Approved |
| 00887056 | NAPROXEN-NA | PRO DOC LIMITEE | Tablet | NAPROXEN SODIUM 275 MG | Marketed |
| 02153386 | NAPROXEN-NA DF | PRO DOC LIMITEE | Tablet | NAPROXEN SODIUM 550 MG | Marketed |
| 02506378 | PAIN RELIEVER & SLEEP AID | APOTEX INC | Tablet | NAPROXEN SODIUM 220 MG; DIPHENHYDRAMINE HYDROCHLORIDE 25 MG | Approved |
| 00778389 | TEVA-NAPROXEN SODIUM | TEVA CANADA LIMITED | Tablet | NAPROXEN SODIUM 275 MG | Marketed |
| 02026600 | TEVA-NAPROXEN SODIUM DS | TEVA CANADA LIMITED | Tablet | NAPROXEN SODIUM 550 MG | Marketed |
| 02463695 | WAYMADE-NAPROXEN SODIUM | WAYMADE PLC | Tablet | NAPROXEN SODIUM 275 MG | Approved |
| 02463709 | WAYMADE-NAPROXEN SODIUM DS | WAYMADE PLC | Tablet | NAPROXEN SODIUM 550 MG | Approved |
| 00491772 | ANAPROX | SYNTEX INC. | Tablet | NAPROXEN SODIUM 275 MG | Cancelled Post Market |
| 00869031 | ANAPROX DS TAB 550MG | SYNTEX INC. | Tablet | NAPROXEN SODIUM 550 MG | Cancelled Post Market |
| 02423790 | MOTRIMAX 12 HOUR TABLETS | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | Tablet | NAPROXEN SODIUM 220 MG | Cancelled Pre Market |
| 02408759 | NAPROXEN | DOMINION PHARMACAL | Tablet | NAPROXEN SODIUM 220 MG | Cancelled Post Market |
| 02378418 | NAPROXEN | PERRIGO INTERNATIONAL | Tablet | NAPROXEN SODIUM 220 MG | Cancelled Post Market |
| 02422743 | NAPROXEN CAPSULES 200 MG | ACCUCAPS INDUSTRIES LIMITED | Capsule | NAPROXEN SODIUM 105 MG; NAPROXEN 105 MG | Cancelled Pre Market |
| 02351013 | NAPROXEN SODIUM | SANIS HEALTH INC | Tablet | NAPROXEN SODIUM 275 MG | Cancelled Post Market |
| 02351021 | NAPROXEN SODIUM DS | SANIS HEALTH INC | Tablet | NAPROXEN SODIUM 550 MG | Cancelled Post Market |
| 02385007 | NAPROXEN SODIUM TABLETS | APOTEX INC | Tablet | NAPROXEN SODIUM 220 MG | Dormant |
| 02347334 | NTP-NAPROXEN SODIUM | TEVA CANADA LIMITED | Tablet | NAPROXEN SODIUM 275 MG | Cancelled Pre Market |
| 02347369 | NTP-NAPROXEN SODIUM DS | TEVA CANADA LIMITED | Tablet | NAPROXEN SODIUM 550 MG | Cancelled Pre Market |
| 02336596 | NU-NAPRO-NA | NU-PHARM INC | Tablet | NAPROXEN SODIUM 275 MG | Cancelled (Unreturned Annual) |
| 02336618 | NU-NAPRO-NA DS | NU-PHARM INC | Tablet | NAPROXEN SODIUM 550 MG | Cancelled (Unreturned Annual) |
| 02378663 | NX 12 HOUR | PERRIGO INTERNATIONAL | Tablet | NAPROXEN SODIUM 220 MG | Cancelled Pre Market |
| 02240827 | RIVA-NAPROXEN SODIUM | LABORATOIRE RIVA INC. | Tablet | NAPROXEN SODIUM 275 MG | Cancelled Post Market |
| 02240828 | RIVA-NAPROXEN SODIUM DS | LABORATOIRE RIVA INC. | Tablet | NAPROXEN SODIUM 550 MG | Cancelled Post Market |
| 01900897 | SYNFLEX DS TAB 550MG | ALTIMED PHARMA INC. | Tablet | NAPROXEN SODIUM 550 MG | Cancelled Post Market |
| 00675369 | SYNFLEX TAB 275MG | ALTIMED PHARMA INC. | Tablet | NAPROXEN SODIUM 275 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22007 | 2019-03-27 | Supplement to a New Drug Submission (SNDS) | CHANGES TO THE PRODUCT LABELLING TO COMPLY WITH THE PLAIN LANGUAGE LABELLING REQUIREMENTS |
| 17185 | 2015-08-11 | New Drug Submission (NDS) |
International API supply for NAPROXEN SODIUM
6 valid EDQM Certificates of Suitability from 6 holders. 10 active FDA Drug Master Files.
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