01 1Apotex Pharmachem
01 1RISEDRONATE SODIUM HEMIPENTAHYDRATE USP
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-16
Pay. Date : 2014-10-14
DMF Number : 21819
Submission : 2008-07-18
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 RISEDRONATE SODIUM HEMIPENTAHYDRATE USP, with a corresponding US DMF Number 21819.
Remarkably, this DMF maintains an Active status since its submission on July 18, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 16, 2014, and payment made on October 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
