01 1Apotex Pharmachem
01 1OLANZAPINE FORM II USP
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-30
Pay. Date : 2022-07-18
DMF Number : 37122
Submission : 2022-07-28
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 OLANZAPINE FORM II USP, with a corresponding US DMF Number 37122.
Remarkably, this DMF maintains an Active status since its submission on July 28, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 30, 2022, and payment made on July 18, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
