01 1Olon S.p.A
01 1UMECLIDINIUM BROMIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-30
Pay. Date : 2023-01-13
DMF Number : 37680
Submission : 2023-03-08
Status : Active
Type : II
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Olon Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is UMECLIDINIUM BROMIDE, with a corresponding US DMF Number 37680.
Remarkably, this DMF maintains an Active status since its submission on March 08, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2023, and payment made on January 13, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
