01 1F.I.S. Fabbrica Italiana Sintetici
01 1MIDAZOLAM HCI
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-29
Pay. Date : 2018-02-20
DMF Number : 25204
Submission : 2011-08-01
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 MIDAZOLAM HCI, with a corresponding US DMF Number 25204.
Remarkably, this DMF maintains an Active status since its submission on August 01, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 29, 2018, and payment made on February 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
