01 1F.I.S. Fabbrica Italiana Sintetici
01 1TEMAZEPAM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-12-18
DMF Number : 5223
Submission : 1983-12-16
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 TEMAZEPAM, with a corresponding US DMF Number 5223.
Remarkably, this DMF maintains an Active status since its submission on December 16, 1983, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2015, and payment made on December 18, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
