01 1F.I.S. Fabbrica Italiana Sintetici
01 1NEBIVOLOL HYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-13
Pay. Date : 2014-10-06
DMF Number : 22735
Submission : 2009-03-31
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 NEBIVOLOL HYDROCHLORIDE, with a corresponding US DMF Number 22735.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 13, 2014, and payment made on October 06, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
