MINT-HYDRALAZINE DIN 02468794
Status: Marketed
Holder: MINT PHARMACEUTICALS INC
Molecule: HYDRALAZINE HYDROCHLORIDE
Available to quote
Health Canada record
| Active ingredient(s) | HYDRALAZINE HYDROCHLORIDE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C02DB02 HYDRALAZINE |
| Original market date | 16-Feb-2018 |
| Current status date | 16-Feb-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mint Pharmaceuticals Inc — licence 101613, currently licensed, last inspection rating C (2023-01-16).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing HYDRALAZINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00441619 | APO-HYDRALAZINE | APOTEX INC | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Marketed |
| 00441627 | APO-HYDRALAZINE | APOTEX INC | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Marketed |
| 00441635 | APO-HYDRALAZINE | APOTEX INC | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Marketed |
| 02493667 | ASN-HYDRALAZINE | ASCEND LABORATORIES LTD | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Approved |
| 02493659 | ASN-HYDRALAZINE | ASCEND LABORATORIES LTD | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Approved |
| 02493640 | ASN-HYDRALAZINE | ASCEND LABORATORIES LTD | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Approved |
| 02539802 | HYDRALAZINE | SANIS HEALTH INC | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Marketed |
| 02539829 | HYDRALAZINE | SANIS HEALTH INC | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Marketed |
| 02539810 | HYDRALAZINE | SANIS HEALTH INC | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Marketed |
| 02406012 | HYDRALAZINE HYDROCHLORIDE INJECTION | FRESENIUS KABI CANADA LTD | Solution | HYDRALAZINE HYDROCHLORIDE 20 MG | Approved |
| 02516160 | HYDRALAZINE HYDROCHLORIDE INJECTION, USP | AURO PHARMA INC | Solution | HYDRALAZINE HYDROCHLORIDE 20 MG | Marketed |
| 02537699 | HYDRALAZINE HYDROCHLORIDE INJECTION, USP | EUGIA PHARMA INC. | Solution | HYDRALAZINE HYDROCHLORIDE 20 MG | Marketed |
| 02457881 | JAMP-HYDRALAZINE | JAMP PHARMA CORPORATION | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Marketed |
| 02457873 | JAMP-HYDRALAZINE | JAMP PHARMA CORPORATION | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Marketed |
| 02457865 | JAMP-HYDRALAZINE | JAMP PHARMA CORPORATION | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Marketed |
| 02468786 | MINT-HYDRALAZINE | MINT PHARMACEUTICALS INC | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Marketed |
| 02468778 | MINT-HYDRALAZINE | MINT PHARMACEUTICALS INC | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Marketed |
| 00723754 | APRESOLINE | STERIMAX INC | Solution | HYDRALAZINE HYDROCHLORIDE 20 MG | Dormant |
| 00005525 | APRESOLINE TABLETS, 10MG | STERIMAX INC | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00005533 | APRESOLINE TABLETS, 25MG | STERIMAX INC | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 00005541 | APRESOLINE TABLETS, 50MG | STERIMAX INC | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 01913638 | HYDRALAZINE-10 TAB 10MG | PRO DOC LIMITEE | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02082071 | HYDRALAZINE-25 TAB | PRO DOC LIMITEE | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 02082098 | HYDRALAZINE-50 TAB | PRO DOC LIMITEE | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 00759465 | NOVO-HYLAZIN TAB 10MG USP | NOVOPHARM LIMITED | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 00759473 | NOVO-HYLAZIN TAB 25MG | NOVOPHARM LIMITED | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 00759481 | NOVO-HYLAZIN TAB 50MG | NOVOPHARM LIMITED | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 01913204 | NU-HYDRAL TAB 10MG | NU-PHARM INC | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02004828 | NU-HYDRAL TAB 25MG | NU-PHARM INC | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Cancelled Post Market |
| 02004836 | NU-HYDRAL TAB 50 MG | NU-PHARM INC | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02231566 | PMS-HYDRALAZINE | PHARMASCIENCE INC | Tablet | HYDRALAZINE HYDROCHLORIDE 50 MG | Cancelled Pre Market |
| 02231564 | PMS-HYDRALAZINE | PHARMASCIENCE INC | Tablet | HYDRALAZINE HYDROCHLORIDE 10 MG | Cancelled Pre Market |
| 02231565 | PMS-HYDRALAZINE | PHARMASCIENCE INC | Tablet | HYDRALAZINE HYDROCHLORIDE 25 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19874 | 2017-10-02 | Abbreviated New Drug Submission (ANDS) |
International API supply for HYDRALAZINE HYDROCHLORIDE
6 valid EDQM Certificates of Suitability from 6 holders. 14 active FDA Drug Master Files.
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