01 1Apotex Pharmachem
01 1OLANZAPINE USP
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-02-25
Pay. Date : 2025-02-20
DMF Number : 29444
Submission : 2015-06-22
Status : Active
Type : II
20
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 OLANZAPINE USP, with a corresponding US DMF Number 29444.
Remarkably, this DMF maintains an Active status since its submission on June 22, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2025, and payment made on February 20, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
