01 1Olon S.p.A
01 1HYDROXYUREA
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-26
Pay. Date : 2022-05-31
DMF Number : 37146
Submission : 2022-06-09
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 HYDROXYUREA, with a corresponding US DMF Number 37146.
Remarkably, this DMF maintains an Active status since its submission on June 09, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 26, 2022, and payment made on May 31, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
