01 1F.I.S. Fabbrica Italiana Sintetici
01 1PROGESTERONE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-22
Pay. Date : 2012-12-10
DMF Number : 22096
Submission : 2008-11-20
Status : Active
Type : II
20
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 PROGESTERONE, with a corresponding US DMF Number 22096.
Remarkably, this DMF maintains an Active status since its submission on November 20, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 22, 2013, and payment made on December 10, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
