01 1Olon S.p.A
01 1ROTIGOTINE POLYMORPH II
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2013-10-23
DMF Number : 27554
Submission : 2013-09-13
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 ROTIGOTINE POLYMORPH II, with a corresponding US DMF Number 27554.
Remarkably, this DMF maintains an Active status since its submission on September 13, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on October 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
