01 1Synthesia
01 1ERGOCALCIFEROL USP
01 1Czech Republic
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-14
Pay. Date : 2014-01-22
DMF Number : 11142
Submission : 1994-10-18
Status : Active
Type : II
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Synthesia As, based in Czech Republic, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ERGOCALCIFEROL USP, with a corresponding US DMF Number 11142.
Remarkably, this DMF maintains an Active status since its submission on October 18, 1994, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 14, 2014, and payment made on January 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
