01 1Olon S.p.A
01 1VALGANCICLOVIR HCL AMORPHOUS TYPE II
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-30
Pay. Date : 2023-08-03
DMF Number : 38635
Submission : 2023-08-04
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 VALGANCICLOVIR HCL AMORPHOUS TYPE II, with a corresponding US DMF Number 38635.
Remarkably, this DMF maintains an Active status since its submission on August 04, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 30, 2023, and payment made on August 03, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
