01 1Olon S.p.A
01 1ZANUBRUTINIB
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2023-05-10
DMF Number : 38350
Submission : 2023-05-12
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 ZANUBRUTINIB, with a corresponding US DMF Number 38350.
Remarkably, this DMF maintains an Active status since its submission on May 12, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 27, 2023, and payment made on May 10, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
