ATARAX DIN 00024694
Health Canada record
| Active ingredient(s) | HYDROXYZINE HYDROCHLORIDE 10 MG |
|---|---|
| Dosage form | Syrup |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05BB01 HYDROXYZINE |
| Original market date | 31-Dec-1956 |
| Current status date | 14-Oct-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Searchlight Pharma Inc — licence 102247, currently licensed, last inspection rating C (2024-10-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing HYDROXYZINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00646016 | HYDROXYZINE | AA PHARMA INC | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Marketed |
| 00646059 | HYDROXYZINE | AA PHARMA INC | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Marketed |
| 00646024 | HYDROXYZINE | AA PHARMA INC | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Marketed |
| 00742813 | HYDROXYZINE HYDROCHLORIDE INJECTION USP | SANDOZ CANADA INCORPORATED | Liquid | HYDROXYZINE HYDROCHLORIDE 50 MG | Marketed |
| 00024376 | ATARAX CAP 10MG | ERFA CANADA 2012 INC | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00024384 | ATARAX CAP 25MG | ERFA CANADA 2012 INC | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 00024392 | ATARAX CAP 50MG | ERFA CANADA 2012 INC | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 00024589 | ATARAX IM SOL 50MG/ML | ERFA CANADA 2012 INC | Solution | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02242864 | HYDROXYZINE HYDROCHLORIDE INJECTION | FRESENIUS KABI CANADA LTD | Liquid | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Pre Market |
| 02231209 | HYDROXYZINE HYDROCHLORIDE INJECTION, USP | STERIMAX INC | Solution | HYDROXYZINE HYDROCHLORIDE 50 MG | Dormant |
| 00739618 | HYDROXYZINE-10 | PRO DOC LIMITEE | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00739626 | HYDROXYZINE-25 | PRO DOC LIMITEE | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 00739634 | HYDROXYZINE-50 | PRO DOC LIMITEE | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 01927876 | MULTIPAX CAP 10MG | RHONE-POULENC RORER CANADA INC. | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 01938835 | MULTIPAX CAP 25MG | RHONE-POULENC RORER CANADA INC. | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 00738824 | NOVO-HYDROXYZIN | TEVA CANADA LIMITED | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Dormant |
| 00738832 | NOVO-HYDROXYZIN | TEVA CANADA LIMITED | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Dormant |
| 00738840 | NOVO-HYDROXYZIN | TEVA CANADA LIMITED | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Dormant |
| 02166313 | NU-HYDROXYZINE | NU-PHARM INC | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02166321 | NU-HYDROXYZINE | NU-PHARM INC | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 02166348 | NU-HYDROXYZINE | NU-PHARM INC | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 00741884 | PMS HYDROXYZINE CAP 10MG | PHARMASCIENCE INC | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00741892 | PMS HYDROXYZINE CAP 25MG | PHARMASCIENCE INC | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 00741906 | PMS HYDROXYZINE CAP 50MG | PHARMASCIENCE INC | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 00741817 | PMS HYDROXYZINE SYR 10MG/5ML | PHARMASCIENCE INC | Syrup | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02241192 | RIVA-HYDROXYZIN 10MG CAPSULES | LABORATOIRE RIVA INC. | Capsule | HYDROXYZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02241193 | RIVA-HYDROXYZIN 25MG CAPSULES | LABORATOIRE RIVA INC. | Capsule | HYDROXYZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 02241194 | RIVA-HYDROXYZIN 50MG CAPSULES | LABORATOIRE RIVA INC. | Capsule | HYDROXYZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 29201 | 2022-10-14 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 18132 | 2016-05-11 | Supplement to a New Drug Submission (SNDS) | UPDATE TO PRODUCT MONOGRAPH: ADDITION OF A WARNING FOR QT PROLANGATION |
| 7290 | 2005-08-17 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
International API supply for HYDROXYZINE HYDROCHLORIDE
6 valid EDQM Certificates of Suitability from 6 holders. 10 active FDA Drug Master Files.
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