01 1F.I.S. Fabbrica Italiana Sintetici
01 1SULINDAC
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-04
DMF Number : 6187
Submission : 1986-02-11
Status : Active
Type : II
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Fis Fabbrica Italiana Sintetici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SULINDAC, with a corresponding US DMF Number 6187.
Remarkably, this DMF maintains an Active status since its submission on February 11, 1986, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2017, and payment made on October 04, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
