01 1Apotex Pharmachem
01 1VILOXAZINE HYDROCHLORIDE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-17
Pay. Date : 2024-10-21
DMF Number : 40648
Submission : 2024-11-07
Status : Active
Type : II
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Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is VILOXAZINE HYDROCHLORIDE, with a corresponding US DMF Number 40648.
Remarkably, this DMF maintains an Active status since its submission on November 07, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 17, 2024, and payment made on October 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
