01 1F.I.S. Fabbrica Italiana Sintetici
01 1CLOBAZAM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-02
Pay. Date : 2015-03-11
DMF Number : 24728
Submission : 2011-02-28
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 CLOBAZAM, with a corresponding US DMF Number 24728.
Remarkably, this DMF maintains an Active status since its submission on February 28, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 02, 2015, and payment made on March 11, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
