01 1Synthon Pharmaceuticals
01 1PALBOCICLIB
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-08
Pay. Date : 2020-04-06
DMF Number : 34761
Submission : 2020-04-14
Status : Active
Type : II
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Synthon Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is PALBOCICLIB, with a corresponding US DMF Number 34761.
Remarkably, this DMF maintains an Active status since its submission on April 14, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 08, 2020, and payment made on April 06, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
