01 1F.I.S. Fabbrica Italiana Sintetici
01 1NITROFURANTOIN MONOHYDRATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-10
DMF Number : 13266
Submission : 1998-10-05
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, with a corresponding US DMF Number 13266.
Remarkably, this DMF maintains an Active status since its submission on October 05, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 11, 2013, and payment made on December 10, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
