NAT-CETIRIZINE DIN 02496461
Health Canada record
| Active ingredient(s) | CETIRIZINE HYDROCHLORIDE 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | NON-PRESCRIPTION DRUGS |
| Class | Human |
| ATC | R06AE07 CETIRIZINE |
| Original market date | 20-Aug-2020 |
| Current status date | 20-Aug-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Natco Pharma (Canada) Inc — licence 102058, currently licensed, last inspection rating C (2022-07-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CETIRIZINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02240266 | ALLERGY RELIEF | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02355868 | ALLERGY RELIEF 10 MG | VITA HEALTH PRODUCTS INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Approved |
| 02516497 | ALLERGY RELIEF CETIRIZINE HYDROCHLORIDE LIQUID GELS | STRIDES PHARMA CANADA INC | Capsule (Immediate-Release) | CETIRIZINE HYDROCHLORIDE 10 MG | Approved |
| 02528738 | ALLERGY RELIEF LIQUID GELS | JUNO OTC INC | Capsule | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02231603 | APO-CETIRIZINE | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02453363 | APO-CETIRIZINE | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02510030 | BIO-CETIRIZINE | BIOMED PHARMA | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02517558 | CETIRIZINE | JAMP PHARMA CORPORATION | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Approved |
| 02515695 | CETIRIZINE | SANIS HEALTH INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02534126 | CETIRIZINE | SIVEM PHARMACEUTICALS ULC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02375087 | CETIRIZINE | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Approved |
| 02482959 | CETIRIZINE HYDROCHLORIDE CAPSULES | CATALENT ONTARIO LIMITED | Capsule | CETIRIZINE HYDROCHLORIDE 10 MG | Approved |
| 02533154 | CETIRIZINE HYDROCHLORIDE TABLETS | VITA HEALTH PRODUCTS INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Approved |
| 02315955 | EXTRA STRENGTH ALLERGY RELIEF | PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02425955 | IPG-CETIRIZINE | MARCAN PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Approved |
| 02425971 | IPG-CETIRIZINE | MARCAN PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Approved |
| 02425963 | IPG-CETIRIZINE | MARCAN PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Approved |
| 02451778 | JAMP-CETIRIZINE | JAMP PHARMA CORPORATION | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02466171 | JAMP-CETIRIZINE | JAMP PHARMA CORPORATION | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02512025 | M-CETIRIZINE | MANTRA PHARMA INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02427125 | MAR-CETIRIZINE | MARCAN PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Approved |
| 02427141 | MAR-CETIRIZINE | MARCAN PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02496488 | NAT-CETIRIZINE | NATCO PHARMA (CANADA) INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02530236 | NRA-CETIRIZINE TABLETS | NORA PHARMA INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02315963 | PMS-CETIRIZINE | PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02450526 | PRO-CETIRIZINE | PRO DOC LIMITEE | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02223554 | REACTINE | KENVUE CANADA INC. | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02223546 | REACTINE | KENVUE CANADA INC. | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Marketed |
| 02238337 | REACTINE | KENVUE CANADA INC. | Syrup | CETIRIZINE HYDROCHLORIDE 5 MG | Marketed |
| 01900978 | REACTINE 20 MG TABLET | KENVUE CANADA INC. | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02486954 | REACTINE ALLERGY | KENVUE CANADA INC. | Syrup | CETIRIZINE HYDROCHLORIDE 5 MG | Marketed |
| 02368064 | REACTINE ALLERGY LIQUID GELS | KENVUE CANADA INC. | Capsule (Immediate-Release) | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02246162 | REACTINE COMPLETE | KENVUE CANADA INC. | Tablet (Extended-Release) | CETIRIZINE HYDROCHLORIDE 5 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG | Marketed |
| 02358352 | REACTINE FAST MELT JUNIOR | KENVUE CANADA INC. | Tablet (Orally-Disintegrating) | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02467577 | REACTINE RAPID DISSOLVE | KENVUE CANADA INC. | Tablet (Orally-Disintegrating) | CETIRIZINE HYDROCHLORIDE 10 MG | Marketed |
| 02318881 | RHINARIS RELIEF | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Approved |
| 02318873 | RHINARIS RELIEF | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Approved |
| 02318903 | RHINARIS RELIEF | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Approved |
| 02528681 | TEVA-CETIRIZINE | TEVA CANADA LIMITED | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Marketed |
| 02524910 | AG-CETIRIZINE | ANGITA PHARMA INC. | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Dormant |
| 02240265 | ALLER-RELIEF | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Dormant |
| 02364689 | ALLER-RELIEF 10MG | PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02315947 | ALLERGY RELIEF | PHARMASCIENCE INC | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Cancelled Pre Market |
| 02432722 | ALLERGY RELIEF LIQUID GELS | APOTEX INC | Capsule | CETIRIZINE HYDROCHLORIDE 10 MG | Dormant |
| 02240910 | APO-CETIRIZINE | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Dormant |
| 02375095 | CETIRIZINE | APOTEX INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Dormant |
| 02517566 | CETIRIZINE EXTRA STRENGTH | JAMP PHARMA CORPORATION | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Dormant |
| 02344572 | DOM-CETIRIZINE | DOMINION PHARMACAL | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Cancelled Pre Market |
| 02408732 | EXTRA STRENGTH ALLERGY RELIEF | DOMINION PHARMACAL | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02517353 | JAMP CETIRIZINE TABLETS | JAMP PHARMA CORPORATION | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Dormant |
| 02451751 | JAMP-CETIRIZINE | JAMP PHARMA CORPORATION | Tablet | CETIRIZINE HYDROCHLORIDE 5 MG | Dormant |
| 02427133 | MAR-CETIRIZINE | MARCAN PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Dormant |
| 02491125 | MINT-CETIRIZINE | MINT PHARMACEUTICALS INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Dormant |
| 02316609 | NOVO-CETIRIZINE | NOVOPHARM LIMITED | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Cancelled Pre Market |
| 02521806 | NRA-CETIRIZINE | NORA PHARMA INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02427192 | PRIVA-CETIRIZINE | PHARMAPAR INC | Tablet | CETIRIZINE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02295067 | REACTINE CHEWABLE TABLETS 10 MG | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | Tablet (Chewable) | CETIRIZINE HYDROCHLORIDE 10 MG | Cancelled Pre Market |
| 02295059 | REACTINE CHEWABLE TABLETS 5 MG | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | Tablet (Chewable) | CETIRIZINE HYDROCHLORIDE 5 MG | Cancelled Pre Market |
| 01900986 | REACTINE TAB 10MG | PFIZER CANADA ULC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02145790 | ZYRTEC - TAB 10MG | UCB INC | Tablet | CETIRIZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32438 | 2023-12-29 | Supplement to an Abbreviated New Drug Submission (SANDS) | Update to Product Monograph to be in line with CRP |
| 23235 | 2020-02-21 | Abbreviated New Drug Submission (ANDS) |
International API supply for CETIRIZINE HYDROCHLORIDE
12 active FDA Drug Master Files.
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