01 1Olon S.p.A
01 1FLUOXETINE HCL EP/USP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-06
Pay. Date : 2016-07-27
DMF Number : 21895
Submission : 2008-08-08
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 FLUOXETINE HCL EP/USP, with a corresponding US DMF Number 21895.
Remarkably, this DMF maintains an Active status since its submission on August 08, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 06, 2017, and payment made on July 27, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
