01 1F.I.S. Fabbrica Italiana Sintetici
01 1OLOPATADINE HYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-06-24
DMF Number : 26297
Submission : 2012-08-02
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 OLOPATADINE HYDROCHLORIDE, with a corresponding US DMF Number 26297.
Remarkably, this DMF maintains an Active status since its submission on August 02, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2013, and payment made on June 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
