01 1F.I.S. Fabbrica Italiana Sintetici
01 1DIAZEPAM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-24
Pay. Date : 2013-05-13
DMF Number : 3164
Submission : 1978-02-28
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 DIAZEPAM, with a corresponding US DMF Number 3164.
Remarkably, this DMF maintains an Active status since its submission on February 28, 1978, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2012, and payment made on May 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
