01 1PHF SA
01 1FLUVASTATIN SODIUM HYDRATE USP
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-25
Pay. Date : 2018-10-22
DMF Number : 18911
Submission : 2005-10-11
Status : Active
Type : II
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Fis Fabbrica Italiana Sintetici Spa, based in Switzerland, is a pharmaceutical company.
One of their notable products is FLUVASTATIN SODIUM HYDRATE USP, with a corresponding US DMF Number 18911.
Remarkably, this DMF maintains an Active status since its submission on October 11, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 25, 2018, and payment made on October 22, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
