01 1Apotex Pharmachem
01 1FESOTERODINE FUMARATE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-23
DMF Number : 26345
Submission : 2012-08-17
Status : Active
Type : II
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Signa Sa De Cv, 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 FESOTERODINE FUMARATE, with a corresponding US DMF Number 26345.
Remarkably, this DMF maintains an Active status since its submission on August 17, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2013, and payment made on November 23, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
