01 1Olon S.p.A
01 1ISOTRETINOIN
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-14
Pay. Date : 2012-12-10
DMF Number : 7485
Submission : 1988-05-16
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 ISOTRETINOIN, with a corresponding US DMF Number 7485.
Remarkably, this DMF maintains an Active status since its submission on May 16, 1988, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 14, 2013, and payment made on December 10, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
