01 1Gedeon Richter
01 1ETONOGESTREL
01 1Hungary
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-22
Pay. Date : 2014-03-26
DMF Number : 11997
Submission : 1996-06-10
Status : Active
Type : II
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Gedeon Richter Plc, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ETONOGESTREL, with a corresponding US DMF Number 11997.
Remarkably, this DMF maintains an Active status since its submission on June 10, 1996, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 22, 2014, and payment made on March 26, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
