01 1F.I.S. Fabbrica Italiana Sintetici
01 1NITROFURANTOIN MONOHYDRATE (CODE 1042-1026)
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2014-12-18
DMF Number : 21887
Submission : 2008-08-05
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 NITROFURANTOIN MONOHYDRATE (CODE 1042-1026), with a corresponding US DMF Number 21887.
Remarkably, this DMF maintains an Active status since its submission on August 05, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2015, and payment made on December 18, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
