01 1Procos
01 1FELBAMATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-03
Pay. Date : 2015-02-13
DMF Number : 21247
Submission : 2008-01-14
Status : Active
Type : II
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Procos Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is FELBAMATE, with a corresponding US DMF Number 21247.
Remarkably, this DMF maintains an Active status since its submission on January 14, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 03, 2016, and payment made on February 13, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
