01 1Apotex Pharmachem
01 1VILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-31
Pay. Date : 2014-06-17
DMF Number : 28343
Submission : 2014-07-18
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 VILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE, with a corresponding US DMF Number 28343.
Remarkably, this DMF maintains an Active status since its submission on July 18, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2014, and payment made on June 17, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
