01 1Apotex Pharmachem
01 1FLUTICASONE PROPIONATE USP (MICRONIZED)
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-10
Pay. Date : 2020-12-07
DMF Number : 35393
Submission : 2020-12-30
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 FLUTICASONE PROPIONATE USP (MICRONIZED), with a corresponding US DMF Number 35393.
Remarkably, this DMF maintains an Active status since its submission on December 30, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 10, 2021, and payment made on December 07, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
