01 1F.I.S. Fabbrica Italiana Sintetici
01 1OXCARBAZEPINE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-21
Pay. Date : 2013-09-20
DMF Number : 16597
Submission : 2003-05-15
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 OXCARBAZEPINE, with a corresponding US DMF Number 16597.
Remarkably, this DMF maintains an Active status since its submission on May 15, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 21, 2014, and payment made on September 20, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
